A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00069121
Collaborator
(none)
1,886
232
2
96.1
8.1
0.1
Study Details
Study Description
Brief Summary
This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either
- XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
1886 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)
Actual Study Start Date
:
Apr 18, 2003
Actual Primary Completion Date
:
Apr 21, 2011
Actual Study Completion Date
:
Apr 21, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 5-Fluorouracil/Leucovorin (5-FU/LV) Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks). |
Drug: Leucovorin (LV)
Administered by one of two regimens, as specified in the arm description.
Drug: 5-Fluorouracil (5-FU)
Administered by one of two regimens, as specified in the arm description.
|
| Experimental: Capecitabine in Combination with Oxaliplatin (XELOX) Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks). |
Drug: Capecitabine
1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.
Other Names:
Drug: Oxaliplatin
130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
|
Outcome Measures
Primary Outcome Measures
- Disease-Free Survival (DFS) [Number of Events] [Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).]
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
- Disease-Free Survival (DFS) [Time to Event] [Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).]
Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
Secondary Outcome Measures
- Relapse-Free Survival (RFS) [Number of Events] [Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).]
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
- Relapse-Free Survival (RFS) [Time to Event] [Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).]
A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- Overall Survival [Number of Events] [Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).]
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
- Overall Survival [Time to Event] [Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).]
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
- Number of Participants With at Least One Adverse Event by Most Severe Intensity [From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).]
The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
-
Complete tumor resection; Patients operated with curative intent and with no macroscopic or microscopic evidence for remaining tumor who can be randomized to either treatment arm within 8 weeks after surgery. As this is an adjuvant trial patients should never have had any evidence of metastatic disease (including presence of tumor cells in the ascites).
-
Have a life expectancy of at least 5 years
Exclusion Criteria:
-
Pregnant or lactating women
-
Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
-
Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated colon cancer
-
Patients who have not completely recovered from surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Cancer Center At Providence Park | Mobile | Alabama | United States | 36608 |
| 2 | Central Hematology Oncology Medical Group Inc. | Alhambra | California | United States | 91801 |
| 3 | Comprehensive Blood/Cancer Ctr | Bakersfield | California | United States | 93309 |
| 4 | Virginia K. Crossen Cancer Center | Fullerton | California | United States | 92835 |
| 5 | Pacific Shores Medical Group | Long Beach | California | United States | 90813 |
| 6 | West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center | Northridge | California | United States | 91325 |
| 7 | Ventura County Hematology-Oncology Specialists | Oxnard | California | United States | 93030 |
| 8 | Wilshire Oncology Medical Group | Pomona | California | United States | 91767 |
| 9 | Sutter Cancer Center | Sacramento | California | United States | 95816 |
| 10 | Scripps Cancer Center | San Diego | California | United States | 92121 |
| 11 | Kaiser Permanente San Diego; Hepatology Research | San Diego | California | United States | 92154 |
| 12 | Santa Barbara Hematology Oncology Medical Group, Inc. | Santa Barbara | California | United States | 93105 |
| 13 | San Diego Cancer Center'S Medical Group | Vista | California | United States | 92083 |
| 14 | Innovative clinical research institute/American institute of research | Whittier | California | United States | 90603 |
| 15 | University of Colorado Health Science Center; Biomedical Research Bldg. Room 511 | Aurora | Colorado | United States | 80045 |
| 16 | Hematology Oncology Associates | Fort Collins | Colorado | United States | 80528 |
| 17 | Hematology Oncology P.C. | Stamford | Connecticut | United States | 06902 |
| 18 | Georgetown Uni Medical Center; Lombardi Cancer Center | Washington | District of Columbia | United States | 20007 |
| 19 | Lakeland Regional Cancer Center | Lakeland | Florida | United States | 33804-1057 |
| 20 | Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center | Miami | Florida | United States | 33136 |
| 21 | Georgia Cancer Specialists | Atlanta | Georgia | United States | 30341 |
| 22 | Illinois Cancer Care | Peoria | Illinois | United States | 61615 |
| 23 | Hope Center | Terre Haute | Indiana | United States | 47802 |
| 24 | Ochsner Cancer Inst. | New Orleans | Louisiana | United States | 70121 |
| 25 | Park Nicollet Clinic Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
| 26 | St Joseph Oncology | Saint Joseph | Missouri | United States | 64507 |
| 27 | Hematology Oncology Consultants, Inc. | Saint Louis | Missouri | United States | 63136 |
| 28 | Hematology-Oncology Centers of the Northern Rockies | Billings | Montana | United States | 59101 |
| 29 | Great Falls Clinic | Great Falls | Montana | United States | 59405 |
| 30 | Va Medical Center | Reno | Nevada | United States | 89502 |
| 31 | Nh Oncology Hematology, Pa | Hooksett | New Hampshire | United States | 03106 |
| 32 | Morristown Medical Center;Hematology-Oncology Assoc | Morristown | New Jersey | United States | 07962 |
| 33 | Overlook Oncology Center; Summit Medical Group | Summit | New Jersey | United States | 07901 |
| 34 | New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | United States | 87109 |
| 35 | St. Vincent'S Hospital; Comprehensive Care Center | New York | New York | United States | 10011 |
| 36 | Presbyterian Healthcare; Cancer Research Dept | Charlotte | North Carolina | United States | 28233-3549 |
| 37 | Moses Cone Reg Cancer Ctr | Greensboro | North Carolina | United States | 27403 |
| 38 | Carolina Oncology Specialists, PA - Hickory | Hickory | North Carolina | United States | 28602 |
| 39 | Oncology-Hematology of Lehigh Valley, Pc | Bethlehem | Pennsylvania | United States | 18015 |
| 40 | Medical Oncology Associates | Kingston | Pennsylvania | United States | 18704 |
| 41 | Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology | Philadelphia | Pennsylvania | United States | 19104-4283 |
| 42 | Fox Chase-Temple Cancer Center | Philadelphia | Pennsylvania | United States | 19111 |
| 43 | Uni of Pittsburgh Cancer Inst. ; Oncology | Pittsburgh | Pennsylvania | United States | 15232 |
| 44 | West Clinic | Germantown | Tennessee | United States | 38138 |
| 45 | US Oncology | The Woodlands | Texas | United States | 77380 |
| 46 | Intermountain Hematology & Oncology | Salt Lake City | Utah | United States | 84106 |
| 47 | Internal Medicine Associates of Yakima Inc. | Yakima | Washington | United States | 98902 |
| 48 | UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center | Madison | Wisconsin | United States | 53792 |
| 49 | Royal Prince Alfred Hospital; Medical Oncology | Camperdown | New South Wales | Australia | 2050 |
| 50 | Port Macquarie Base Hospital; Oncology | Port Macquarie | New South Wales | Australia | 2444 |
| 51 | Southern Medical Day Care; Clinical Trials Unit | Wollongong | New South Wales | Australia | 2500 |
| 52 | Queen Elizabeth Hospital; Medical Oncology | Woodville South | South Australia | Australia | 5011 |
| 53 | Box Hill Hospital; Oncology | Box Hill | Victoria | Australia | 3128 |
| 54 | Footscray Hospital | Footscray | Victoria | Australia | 3011 |
| 55 | St John of God Hospital; Medical Oncology | Perth | Western Australia | Australia | 6008 |
| 56 | Cliniques Universitaires St-Luc | Bruxelles | Belgium | 1200 | |
| 57 | GHdC Site Notre Dame | Charleroi | Belgium | 6000 | |
| 58 | UZ Gent | Gent | Belgium | 9000 | |
| 59 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
| 60 | UZ Leuven Gasthuisberg | Leuven | Belgium | 3000 | |
| 61 | Hospital de Baleia; Serviço de Oncologia Clínica | Belo Horizonte | MG | Brazil | 30285-000 |
| 62 | Hospital Amaral Carvalho | Jau | SP | Brazil | 17210-120 |
| 63 | Hospital das Clinicas - FMUSP; Gastroenterologia | Sao Paulo | SP | Brazil | 05403-000 |
| 64 | Tom Baker Cancer Centre; Dept of Medicine | Calgary | Alberta | Canada | T2N 4N2 |
| 65 | Cross Cancer Institute ; Dept of Medical Oncology | Edmonton | Alberta | Canada | T6G 1Z2 |
| 66 | Bcca - Cancer Center Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 67 | Bcca-Fraser Valley Cancer Centre | Surrey | British Columbia | Canada | V3V 1Z2 |
| 68 | Bcca - Vancouver Island Cancer Centre; Oncology | Victoria | British Columbia | Canada | V8R 6V5 |
| 69 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
| 70 | Dr. H. Bliss Murphy Cancer Centre; Oncology | St. John's | Newfoundland and Labrador | Canada | A1B 3V6 |
| 71 | Queen Elizabeth II Health Sciences Centre; Oncology | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 72 | Hamilton Health Sciences - Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 73 | London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
| 74 | Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre | Mississauga | Ontario | Canada | L5M 2N1 |
| 75 | Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | Canada | L1G 2B9 |
| 76 | The Ottawa Hospital Cancer Centre; Oncology | Ottawa | Ontario | Canada | K1H 8L6 |
| 77 | Humber River Hospital | Toronto | Ontario | Canada | M3M 0B2 |
| 78 | Sunnybrook Health Science Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 79 | University Health Network; Princess Margaret Hospital; Medical Oncology Dept | Toronto | Ontario | Canada | M5G 2M9 |
| 80 | Cite de La Sante de Laval; Hemato-Oncologie | Laval | Quebec | Canada | H7M 3L9 |
| 81 | Hotel Dieu de Levis; Oncology | Levis | Quebec | Canada | G6V 3Z1 |
| 82 | Hopital Maisonneuve- Rosemont; Oncology | Montreal | Quebec | Canada | H1T 2M4 |
| 83 | Chum Campus Notre Dame | Montreal | Quebec | Canada | H2X 0A9 |
| 84 | McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology | Montreal | Quebec | Canada | H3T 1E2 |
| 85 | Hopital Du Sacre Coeur de Montreal; Pneumologie | Montreal | Quebec | Canada | H4J 1C5 |
| 86 | Chuq - Hopital Hotel Dieu de Quebec; Oncology | Quebec City | Quebec | Canada | G1R 2J6 |
| 87 | Cancer Hospital Chinese Academy of Medical Sciences. | Beijing | China | 100021 | |
| 88 | Nanfang Hospital, Southern Medical University | Guangzhou | China | 510515 | |
| 89 | The Second Affiliated Hospital of Zhejiang University College | Hangzhou | China | 310009 | |
| 90 | The 1st Affiliated Hospital of Nanchang Unversity | Nanchang | China | 330006 | |
| 91 | Jiangsu Cancer Hospital | Nanjing | China | 210009 | |
| 92 | Shandong Cancer Hospital; Oncology | Shandong | China | 250117 | |
| 93 | Fudan University Shanghai Cancer Center | Shanghai City | China | 200120 | |
| 94 | Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) | Shanghai | China | 200025 | |
| 95 | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | China | 200092 | |
| 96 | Tianjin Cancer Hospital | Tianjin | China | 300060 | |
| 97 | Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech | Wuhan | China | 430030 | |
| 98 | Tampere University Hospital; Dept of Oncology | Tampere | Finland | 33520 | |
| 99 | Turku Uni Central Hospital; Oncology Clinics | Turku | Finland | 20520 | |
| 100 | Hopital Louis Pasteur; Medecine B | Colmar | France | 68024 | |
| 101 | Hopital Claude Huriez; Medecine Interne Oncologie | Lille | France | 59037 | |
| 102 | Institut Paoli Calmettes; Oncologie Medicale | Marseille | France | 13273 | |
| 103 | Hopital Civil; Hematologie Oncologie | Strasbourg | France | 67091 | |
| 104 | Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg | Germany | 79110 | |
| 105 | Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV | Halle | Germany | 06120 | |
| 106 | Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie | Magdeburg | Germany | 39130 | |
| 107 | Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie | Trier | Germany | 54290 | |
| 108 | Evangelismos Hospital; Medical Oncology | Athens | Greece | 10676 | |
| 109 | Per. Gen. Hospital Ippokrateion; Oncology Dept. | Athens | Greece | 11527 | |
| 110 | Univ General Hosp Heraklion; Medical Oncology | Heraklion | Greece | 711 10 | |
| 111 | University Hospital of Patras Medical Oncology | Patras | Greece | 265 04 | |
| 112 | Theagenio Anticancer Hospital; 3Rd Oncology Clinic | Thessaloniki | Greece | 546 39 | |
| 113 | Theageneio Anticancer Hospital; Gastroenterology | Thessaloniki | Greece | 56439 | |
| 114 | Queen Mary Hospital; Surgery | Hong Kong | Hong Kong | 852 | |
| 115 | Ogyi, Orszagos Gyogyszereszeti Intezet | Budapest | Hungary | 1051 | |
| 116 | Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X | Budapest | Hungary | 1097 | |
| 117 | Orszagos Onkologial Intezet; Onkologiai Osztaly X | Budapest | Hungary | 1122 | |
| 118 | Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | Hungary | 6720 | |
| 119 | Mercy Uni Hospital; Deparment of Medical Oncology | Cork | Ireland | ||
| 120 | St. James Hospital; Oncology | Dublin | Ireland | 8 | |
| 121 | Galway Uni Hospital; Oncology Dept | Galway | Ireland | ||
| 122 | Soroka Medical Center; Oncology Dept | Beer Sheva | Israel | 8410100 | |
| 123 | Rambam Medical Center; Oncology | Haifa | Israel | 3109601 | |
| 124 | Shaare Zedek Medical Center; Oncology Dept | Jerusalem | Israel | 9103102 | |
| 125 | Hadassah Ein Karem Hospital; Oncology Dept | Jerusalem | Israel | 9112000 | |
| 126 | Meir Medical Center; Oncology | Kfar-Saba | Israel | 4428164 | |
| 127 | Nahariya Hospital; Oncology | Nahariya | Israel | 22100 | |
| 128 | Rabin Medical Center; Oncology Dept | Petach Tikva | Israel | 4941492 | |
| 129 | Golda Hasharon Medical Center; Oncology | Petach Tikva | Israel | ||
| 130 | Chaim Sheba Medical Center; Oncology Dept | Ramat Gan | Israel | 52620-00 | |
| 131 | Kaplan Medical Center; Oncology Inst. | Rehovot | Israel | 7610001 | |
| 132 | Sourasky / Ichilov Hospital; Oncology Department | Tel Aviv | Israel | 64239-06 | |
| 133 | Assaf Harofeh; Oncology | Zerifin | Israel | 6093000 | |
| 134 | Ospedale Cervesi di Cattolica; ONCOLOGIA | Cattolica | Emilia-Romagna | Italy | 47841 |
| 135 | Ospedale Regionale Di Parma; Divisione Di Oncologia Medica | Parma | Emilia-Romagna | Italy | 43100 |
| 136 | Ospedale Degli Infermi; Divisione Di Oncologia | Rimini | Emilia-Romagna | Italy | 47900 |
| 137 | Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia | Udine | Friuli-Venezia Giulia | Italy | 33100 |
| 138 | Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical | Genova | Liguria | Italy | 16132 |
| 139 | Asst Papa Giovanni XXIII; Oncologia Medica | Bergamo | Lombardia | Italy | 24127 |
| 140 | Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milano | Lombardia | Italy | 20141 |
| 141 | A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica | Ancona | Marche | Italy | 60121 |
| 142 | Ospedale Civile; Oncologia Medica | Sassari | Sardegna | Italy | 07100 |
| 143 | Ospedale Civile; Unita Operativa Di Oncologia Medica | Livorno | Toscana | Italy | 57100 |
| 144 | Azienda Usl 7; Dept. Oncologico | Poggibonsi | Toscana | Italy | 53036 |
| 145 | Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology | Seoul | Korea, Republic of | 03080 | |
| 146 | Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology | Seoul | Korea, Republic of | 03722 | |
| 147 | Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology | Seoul | Korea, Republic of | 133-792 | |
| 148 | Samsung Medical Centre; Division of Hematology/Oncology | Seoul | Korea, Republic of | 135-710 | |
| 149 | Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology | Seoul | Korea, Republic of | 138-736 | |
| 150 | Centro Estatal de Cancerología | Chihuahua | Mexico | 31000 | |
| 151 | Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion | Chihuahua | Mexico | 31000 | |
| 152 | Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology | Mexicali | Mexico | 21100 | |
| 153 | Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology | Mexico City | Mexico | 14000 | |
| 154 | Auckland city hospital; Auckland Regional Cancer Centre and Blood Service | Auckland | New Zealand | 1023 | |
| 155 | Christchurch Hospital; Dept of Oncology | Christchurch | New Zealand | ||
| 156 | Dunedin Hospital; Oncology - Haematology Clinical Practice Group | Dunedin | New Zealand | 9016 | |
| 157 | Palmerston North Hospital; Regional Cancer Treatment Service | Palmerston North | New Zealand | 4442 | |
| 158 | Wellington Hospital; Regional Oncology Unit | Wellington | New Zealand | 6002 | |
| 159 | Isthmian Medical Research Center, S.A.; Oncology | Panama City | Panama | ||
| 160 | Rydygiera Hospital; Chemotherapy | Krakow | Poland | 31-826 | |
| 161 | Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych | Lodz | Poland | 93-509 | |
| 162 | Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii | Poznan | Poland | 61-866 | |
| 163 | Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych | Szczecin | Poland | 71-730 | |
| 164 | Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego | Warszawa | Poland | 02-781 | |
| 165 | Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii | Zielona Gora | Poland | 65-046 | |
| 166 | Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica | Beja | Portugal | 7801-849 | |
| 167 | Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa | Portugal | 1649-035 | |
| 168 | IPO do Porto; Servico de Oncologia Medica | Porto | Portugal | 4200-072 | |
| 169 | N.N.Burdenko Main Military Clinical Hospital; Chemotherapy | Moscow | Russian Federation | 105229 | |
| 170 | Blokhin Cancer Research Center; Combined Treatment | Moscow | Russian Federation | 115478 | |
| 171 | Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow | St Petersburg | Russian Federation | 197758 | |
| 172 | St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4) | St Petersburg | Russian Federation | 198255 | |
| 173 | National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | Singapore | 119228 | |
| 174 | National Cancer Centre; Medical Oncology | Singapore | Singapore | 169610 | |
| 175 | Panorama Medical Clinic; Oncology Unit | Cape Town | South Africa | 7500 | |
| 176 | Hopelands Cancer Centre; Oncology | Durban | South Africa | 4001 | |
| 177 | Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY | Pietermaritzburg | South Africa | 3201 | |
| 178 | Little Company of Mary Hospital; Mary Potter Oncology Centre | Pretoria | South Africa | 0001 | |
| 179 | Sandton Oncology Medical Group | Sandton | South Africa | 2196 | |
| 180 | Hospital General Universitario de Elche; Servicio de Oncologia | Elche | Alicante | Spain | 03203 |
| 181 | Hospital Universitario Marques de Valdecilla; Servicio de Oncologia | Santander | Cantabria | Spain | 39008 |
| 182 | Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | Spain | 14004 |
| 183 | Hospital Universitario Son Espases | Palma De Mallorca | Islas Baleares | Spain | 07014 |
| 184 | Hospital Severo Ochoa; Servicio de Oncologia | Leganes | Madrid | Spain | 28911 |
| 185 | Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | Spain | 28222 |
| 186 | Hospital de Cruces; Servicio de Oncologia | Bilbao | Vizcaya | Spain | 48903 |
| 187 | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | Spain | 08035 | |
| 188 | Hospital Clínic i Provincial; Servicio de Hematología y Oncología | Barcelona | Spain | 08036 | |
| 189 | Hospital Duran i Reynals; Oncologia | Barcelona | Spain | 08907 | |
| 190 | Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen | Spain | 23007 | |
| 191 | Hospital Universitario de la Princesa; Servicio de Oncologia | Madrid | Spain | 28006 | |
| 192 | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | Spain | 28007 | |
| 193 | Hospital Universitario Clínico San Carlos; Servicio de Oncologia | Madrid | Spain | 28040 | |
| 194 | Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | Spain | 28041 | |
| 195 | Hospital Universitario La Paz; Servicio de Oncologia | Madrid | Spain | 28046 | |
| 196 | Hospital Regional Universitario Carlos Haya; Servicio de Oncologia | Malaga | Spain | 29010 | |
| 197 | Instituto Valenciano Oncologia; Oncologia Medica | Valencia | Spain | 46009 | |
| 198 | Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | Spain | 46010 | |
| 199 | Hospital Universitario la Fe; Servicio de Oncologia | Valencia | Spain | 46026 | |
| 200 | Universitaetsspital Basel; Onkologie | Basel | Switzerland | 4031 | |
| 201 | Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei City | Taiwan | 11259 | |
| 202 | Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery | Taipei | Taiwan | ||
| 203 | Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery | Taoyuan | Taiwan | 333 | |
| 204 | Bumrungrad Hospital Foundation; Horizon Centre | Bangkok | Thailand | 10110 | |
| 205 | Pramongkutklao Hospital; Medicine - Medical Oncology Unit | Bangkok | Thailand | 10400 | |
| 206 | Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok | Thailand | 10400 | |
| 207 | Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology | Bangkok | Thailand | 10700 | |
| 208 | Srinagarind Hospital; Medical Oncology Unit | Khon Kaen | Thailand | 40002 | |
| 209 | Aberdeen Royal Infirmary; Medical Oncology Dept | Aberdeen | United Kingdom | AB25 2ZN | |
| 210 | The Royal Sussex County Hospital; the Sussex Cancer Centre | Brighton | United Kingdom | BN2 5BE | |
| 211 | West Suffolk Hospital Nhs Trust; Gi Corridor | Bury St Edmunds | United Kingdom | IP33 2QZ | |
| 212 | Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics | Cambridge | United Kingdom | CB2 2QH | |
| 213 | Derbyshire Royal Infirmary; Dept of Oncology | Derby | United Kingdom | DE1 2QY | |
| 214 | Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr | Glasgow | United Kingdom | G12 0YN | |
| 215 | Royal Surrey County Hospital; St. Lukes Cancer Centre | Guildford | United Kingdom | GU2 7XX | |
| 216 | St James Institute of Oncology | Leeds | United Kingdom | LS9 7TF | |
| 217 | Leicester Royal Infirmary; Dept. of Medical Oncology | Leicester | United Kingdom | LE1 5WW | |
| 218 | St Thomas Hospital; Oncology Dept | London | United Kingdom | SE1 7EH | |
| 219 | Royal Marsden Nhs Trust; Consultant Cancer Physician | London | United Kingdom | SW3 6JJ | |
| 220 | Hammersmith Hospital; Mrc Clinical Science Centre | London | United Kingdom | W12 OHS | |
| 221 | Charing Cross Hospital; Medical Oncology. | London | United Kingdom | W6 8RF | |
| 222 | Maidstone Hospital | Maidstone | United Kingdom | ME16 9QQ | |
| 223 | Christie Hospital; Breast Cancer Research Office | Manchester | United Kingdom | M20 4QL | |
| 224 | James Cook Uni Hospital | Middlesborough | United Kingdom | TS4 3BW | |
| 225 | Northern Centre for Cancer Care;Oncology | Newcastle Upon Tyne | United Kingdom | NE7 7DN | |
| 226 | Mount Vernon Hospital; Centre For Cancer Treatment | Northwood | United Kingdom | HA6 2RN | |
| 227 | Nottingham City Hospital; Oncology | Nottingham | United Kingdom | NG5 1PB | |
| 228 | Derriford Hospital; Plymouth Oncology Centre | Plymouth | United Kingdom | PL6 8DH | |
| 229 | North Wales Cancer Treatment Centre, Glan Clwyd Hospital | Rhyl | United Kingdom | LL18 5UJ | |
| 230 | Salisbury District General Hospital; Medical Oncology Dept | Salisbury | United Kingdom | SP2 8BJ | |
| 231 | Southampton General Hospital; Somers Cancer Research Building | Southampton | United Kingdom | SO16 6YD | |
| 232 | Royal Marsden Hospital; Dept of Medical Oncology | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069121
Other Study ID Numbers:
- NO16968
- NCT00080691
First Posted:
Sep 18, 2003
Last Update Posted:
Mar 6, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Period Title: Overall Study | ||
| STARTED | 942 | 944 |
| Received Treatment | 926 | 938 |
| COMPLETED | 575 | 619 |
| NOT COMPLETED | 367 | 325 |
Baseline Characteristics
| Arm/Group Title | 5-FU/LV | XELOX | Total |
|---|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) | Total of all reporting groups |
| Overall Participants | 942 | 944 | 1886 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
60.5
(10.76)
|
59.8
(10.95)
|
60.2
(10.86)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
442
46.9%
|
431
45.7%
|
873
46.3%
|
| Male |
500
53.1%
|
513
54.3%
|
1013
53.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
442
46.9%
|
431
45.7%
|
873
46.3%
|
| Male |
500
53.1%
|
513
54.3%
|
1013
53.7%
|
Outcome Measures
| Title | Disease-Free Survival (DFS) [Number of Events] |
|---|---|
| Description | Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. |
| Time Frame | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat Population |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Patients with Event |
379
40.2%
|
320
33.9%
|
| Patients without Events |
563
59.8%
|
624
66.1%
|
| Title | Relapse-Free Survival (RFS) [Number of Events] |
|---|---|
| Description | A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. |
| Time Frame | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Patients With Event |
356
37.8%
|
290
30.7%
|
| Patients Without Events |
586
62.2%
|
654
69.3%
|
| Title | Disease-Free Survival (DFS) [Time to Event] |
|---|---|
| Description | Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Time Frame | Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Median (Full Range) [months] |
NA
|
88.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5-FU/LV, XELOX |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0038 |
| Comments | This test used a two-sided significance level of 5%. | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.69 to 0.93 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The hazard ratio was calculated as XELOX versus 5-FU/LV arms. | |
| Title | Relapse-Free Survival (RFS) [Time to Event] |
|---|---|
| Description | A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Time Frame | Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Median (Full Range) [months] |
NA
|
88.6
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5-FU/LV, XELOX |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Descriptive analysis only. | |
| Statistical Test of Hypothesis | p-Value | 0.0015 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.78 | |
| Confidence Interval |
(2-Sided) 95% 0.67 to 0.91 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The hazard ratio was calculated as XELOX versus 5-FU/LV arms. | |
| Title | Overall Survival [Number of Events] |
|---|---|
| Description | Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. |
| Time Frame | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Patients With Event |
286
30.4%
|
242
25.6%
|
| Patients Without Events |
656
69.6%
|
702
74.4%
|
| Title | Overall Survival [Time to Event] |
|---|---|
| Description | Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive. The median was estimated by the Kaplan-Meier method. The full range values include censored observations. |
| Time Frame | Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized. |
| Arm/Group Title | 5-FU/LV | XELOX |
|---|---|---|
| Arm/Group Description | Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 942 | 944 |
| Median (Full Range) [months] |
NA
|
NA
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 5-FU/LV, XELOX |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Descriptive analysis only. | |
| Statistical Test of Hypothesis | p-Value | 0.0367 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.83 | |
| Confidence Interval |
(2-Sided) 95% 0.70 to 0.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | The hazard ratio was calculated as XELOX versus 5-FU/LV arms. | |
| Title | Number of Participants With at Least One Adverse Event by Most Severe Intensity |
|---|---|
| Description | The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details. |
| Time Frame | From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received. |
| Arm/Group Title | 5-FU/LV MAYO CLINIC | 5-FU/LV ROSWELL PARK | XELOX |
|---|---|---|---|
| Arm/Group Description | Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks) | Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks) | Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks) |
| Measure Participants | 657 | 269 | 938 |
| Mild AEs |
557
59.1%
|
256
27.1%
|
855
45.3%
|
| Moderate AEs |
493
52.3%
|
217
23%
|
792
42%
|
| Severe AEs |
299
31.7%
|
146
15.5%
|
548
29.1%
|
| Life-Threatening |
83
8.8%
|
21
2.2%
|
63
3.3%
|
Adverse Events
| Time Frame | From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938) | |||||
| Arm/Group Title | 5-FU/LV MAYO CLINIC | 5-FU/LV ROSWELL PARK | XELOX | |||
| Arm/Group Description | 5-fluorouracil/leucovorin | 5-fluorouracil/leucovorin | Capecitabine in Combination with Intravenous Oxaliplatin (Q3W) | |||
All Cause Mortality |
||||||
| 5-FU/LV MAYO CLINIC | 5-FU/LV ROSWELL PARK | XELOX | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 215/664 (32.4%) | 71/278 (25.5%) | 242/944 (25.6%) | |||
Serious Adverse Events |
||||||
| 5-FU/LV MAYO CLINIC | 5-FU/LV ROSWELL PARK | XELOX | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 134/657 (20.4%) | 88/269 (32.7%) | 208/938 (22.2%) | |||
| Blood and lymphatic system disorders | ||||||
| FEBRILE NEUTROPENIA | 31/657 (4.7%) | 2/269 (0.7%) | 2/938 (0.2%) | |||
| NEUTROPENIA | 8/657 (1.2%) | 2/269 (0.7%) | 3/938 (0.3%) | |||
| ANAEMIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| COAGULOPATHY | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| HAEMOLYTIC URAEMIC SYNDROME | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| LEUKOPENIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| THROMBOCYTOPENIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Cardiac disorders | ||||||
| ATRIAL FIBRILLATION | 3/657 (0.5%) | 1/269 (0.4%) | 5/938 (0.5%) | |||
| ACUTE MYOCARDIAL INFARCTION | 0/657 (0%) | 0/269 (0%) | 3/938 (0.3%) | |||
| ANGINA PECTORIS | 2/657 (0.3%) | 0/269 (0%) | 1/938 (0.1%) | |||
| MYOCARDIAL INFARCTION | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ANGINA UNSTABLE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ARRHYTHMIA SUPRAVENTRICULAR | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ATRIOVENTRICULAR BLOCK COMPLETE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CARDIAC ARREST | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| MYOCARDIAL ISCHAEMIA | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| PERICARDIAL EFFUSION | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| TACHYCARDIA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Ear and labyrinth disorders | ||||||
| VERTIGO POSITIONAL | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Eye disorders | ||||||
| EYE MOVEMENT DISORDER | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Gastrointestinal disorders | ||||||
| DIARRHOEA | 39/657 (5.9%) | 24/269 (8.9%) | 55/938 (5.9%) | |||
| STOMATITIS ALL | 22/657 (3.3%) | 0/269 (0%) | 2/938 (0.2%) | |||
| VOMITING | 6/657 (0.9%) | 3/269 (1.1%) | 15/938 (1.6%) | |||
| ABDOMINAL PAIN | 5/657 (0.8%) | 3/269 (1.1%) | 13/938 (1.4%) | |||
| INTESTINAL OBSTRUCTION | 5/657 (0.8%) | 2/269 (0.7%) | 7/938 (0.7%) | |||
| SMALL INTESTINAL OBSTRUCTION | 1/657 (0.2%) | 3/269 (1.1%) | 8/938 (0.9%) | |||
| ILEUS | 2/657 (0.3%) | 4/269 (1.5%) | 3/938 (0.3%) | |||
| NAUSEA | 3/657 (0.5%) | 1/269 (0.4%) | 4/938 (0.4%) | |||
| COLITIS | 1/657 (0.2%) | 1/269 (0.4%) | 3/938 (0.3%) | |||
| ENTERITIS | 2/657 (0.3%) | 2/269 (0.7%) | 1/938 (0.1%) | |||
| GASTROINTESTINAL HAEMORRHAGE | 0/657 (0%) | 0/269 (0%) | 4/938 (0.4%) | |||
| SUBILEUS | 1/657 (0.2%) | 0/269 (0%) | 3/938 (0.3%) | |||
| ABDOMINAL ADHESIONS | 0/657 (0%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| ENTEROCOLITIS | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTRIC HAEMORRHAGE | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTRITIS | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTROINTESTINAL TOXICITY | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| HAEMATEMESIS | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| ILEITIS | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| INTESTINAL ISCHAEMIA | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| LARGE INTESTINAL OBSTRUCTION | 1/657 (0.2%) | 1/269 (0.4%) | 0/938 (0%) | |||
| NEUTROPENIC COLITIS | 1/657 (0.2%) | 1/269 (0.4%) | 0/938 (0%) | |||
| ABDOMINAL MASS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ASCITES | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| CAECITIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| COLITIS ISCHAEMIC | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| COLONIC FISTULA | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| CONSTIPATION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CROHN'S DISEASE | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| GASTRITIS EROSIVE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTROINTESTINAL OBSTRUCTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTROINTESTINAL OEDEMA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| GASTROINTESTINAL ULCER | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| GASTROOESOPHAGEAL REFLUX DISEASE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ILEUS PARALYTIC | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| INTERNAL HERNIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| INTESTINAL PERFORATION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| MECHANICAL ILEUS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| OESOPHAGEAL MASS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PERITONITIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| PNEUMATOSIS INTESTINALIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| SMALL INTESTINAL PERFORATION | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| UPPER GASTROINTESTINAL HAEMORRHAGE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| General disorders | ||||||
| PYREXIA | 2/657 (0.3%) | 3/269 (1.1%) | 12/938 (1.3%) | |||
| CHEST PAIN | 0/657 (0%) | 1/269 (0.4%) | 2/938 (0.2%) | |||
| GENERAL PHYSICAL HEALTH DETERIORATION | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| CHEST DISCOMFORT | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CHILLS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| DISEASE PROGRESSION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| FATIGUE | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| OEDEMA PERIPHERAL | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Hepatobiliary disorders | ||||||
| CHOLELITHIASIS | 0/657 (0%) | 3/269 (1.1%) | 0/938 (0%) | |||
| CHOLECYSTITIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| CHOLECYSTITIS ACUTE | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| HEPATIC LESION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PORTAL VEIN THROMBOSIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Immune system disorders | ||||||
| HYPERSENSITIVITY | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| ANAPHYLACTIC REACTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ANAPHYLACTOID REACTION | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| Infections and infestations | ||||||
| PNEUMONIA | 2/657 (0.3%) | 1/269 (0.4%) | 5/938 (0.5%) | |||
| SEPSIS | 3/657 (0.5%) | 1/269 (0.4%) | 3/938 (0.3%) | |||
| NEUTROPENIC SEPSIS | 5/657 (0.8%) | 0/269 (0%) | 0/938 (0%) | |||
| GASTROENTERITIS | 1/657 (0.2%) | 2/269 (0.7%) | 1/938 (0.1%) | |||
| BACTERAEMIA | 0/657 (0%) | 0/269 (0%) | 3/938 (0.3%) | |||
| CLOSTRIDIAL INFECTION | 1/657 (0.2%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| ANAL ABSCESS | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| INFECTION | 0/657 (0%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| SEPTIC SHOCK | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ABDOMINAL ABSCESS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ABDOMINAL WALL ABSCESS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| BRONCHITIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| BRONCHOPNEUMONIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CELLULITIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CLOSTRIDIUM DIFFICILE COLITIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| DIVERTICULITIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ENDOPHTHALMITIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| HEPATITIS B | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| LOWER RESPIRATORY TRACT INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ORAL CANDIDIASIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| PHARYNGITIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| POSTOPERATIVE WOUND INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| RESPIRATORY TRACT INFECTION | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| SEPSIS SYNDROME | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| SKIN INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| STAPHYLOCOCCAL INFECTION | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| UPPER RESPIRATORY TRACT INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| URINARY TRACT INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| VIRAL INFECTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| FEMUR FRACTURE | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ACCIDENTAL OVERDOSE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| INCISIONAL HERNIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PROCEDURAL SITE REACTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| SUBDURAL HAEMATOMA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| UPPER LIMB FRACTURE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| WOUND DEHISCENCE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Investigations | ||||||
| ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| BLOOD BILIRUBIN ABNORMAL | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CULTURE STOOL POSITIVE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Metabolism and nutrition disorders | ||||||
| DEHYDRATION | 4/657 (0.6%) | 10/269 (3.7%) | 24/938 (2.6%) | |||
| HYPOKALAEMIA | 0/657 (0%) | 0/269 (0%) | 3/938 (0.3%) | |||
| ANOREXIA | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| HYPERGLYCAEMIA | 0/657 (0%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| ACIDOSIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| DIABETIC KETOACIDOSIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| FLUID OVERLOAD | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| HYPONATRAEMIA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRITIS | 1/657 (0.2%) | 1/269 (0.4%) | 0/938 (0%) | |||
| INTERVERTEBRAL DISC DISPLACEMENT | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| MYOSITIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| COLON CANCER | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Nervous system disorders | ||||||
| SYNCOPE | 2/657 (0.3%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| LOSS OF CONSCIOUSNESS | 0/657 (0%) | 0/269 (0%) | 3/938 (0.3%) | |||
| DIZZINESS | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CEREBRAL AMYLOID ANGIOPATHY | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CEREBROVASCULAR ACCIDENT | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ENCEPHALOPATHY | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| HAEMORRHAGIC CEREBRAL INFARCTION | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| HEADACHE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| HEMIPLEGIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ISCHAEMIC STROKE | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| NERVOUS SYSTEM DISORDER | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| NEUROPATHY PERIPHERAL | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PARAESTHESIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PERIPHERAL MOTOR NEUROPATHY | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PERIPHERAL SENSORY NEUROPATHY | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| SCIATICA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| SUPERIOR SAGITTAL SINUS THROMBOSIS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Psychiatric disorders | ||||||
| PSYCHOTIC DISORDER | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Renal and urinary disorders | ||||||
| RENAL FAILURE | 2/657 (0.3%) | 0/269 (0%) | 3/938 (0.3%) | |||
| HAEMATURIA | 1/657 (0.2%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| RENAL COLIC | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| RENAL FAILURE ACUTE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| URINARY RETENTION | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| UROGENITAL HAEMORRHAGE | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| Reproductive system and breast disorders | ||||||
| MENORRHAGIA | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| OVARIAN MASS | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| VAGINAL HAEMORRHAGE | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| PULMONARY EMBOLISM | 4/657 (0.6%) | 5/269 (1.9%) | 3/938 (0.3%) | |||
| DYSPNOEA | 0/657 (0%) | 0/269 (0%) | 3/938 (0.3%) | |||
| DYSAESTHESIA PHARYNX | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| ASTHMA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| BRONCHOSPASM | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| EPISTAXIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| HAEMOPTYSIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| LARYNGOSPASM | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PNEUMONIA ASPIRATION | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| PNEUMOTHORAX | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| PULMONARY OEDEMA | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| DERMATITIS CONTACT | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| RASH | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| Vascular disorders | ||||||
| DEEP VEIN THROMBOSIS | 3/657 (0.5%) | 3/269 (1.1%) | 5/938 (0.5%) | |||
| HYPOTENSION | 0/657 (0%) | 1/269 (0.4%) | 2/938 (0.2%) | |||
| THROMBOSIS | 1/657 (0.2%) | 1/269 (0.4%) | 1/938 (0.1%) | |||
| HYPERTENSION | 0/657 (0%) | 0/269 (0%) | 2/938 (0.2%) | |||
| THROMBOPHLEBITIS | 1/657 (0.2%) | 0/269 (0%) | 1/938 (0.1%) | |||
| ARTERIAL OCCLUSIVE DISEASE | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| HYPOVOLAEMIC SHOCK | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| JUGULAR VEIN THROMBOSIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| NECROSIS OF ARTERY | 1/657 (0.2%) | 0/269 (0%) | 0/938 (0%) | |||
| SUBCLAVIAN VEIN THROMBOSIS | 0/657 (0%) | 1/269 (0.4%) | 0/938 (0%) | |||
| VENA CAVA THROMBOSIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
| VENOUS THROMBOSIS | 0/657 (0%) | 0/269 (0%) | 1/938 (0.1%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| 5-FU/LV MAYO CLINIC | 5-FU/LV ROSWELL PARK | XELOX | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 622/657 (94.7%) | 262/269 (97.4%) | 926/938 (98.7%) | |||
| Blood and lymphatic system disorders | ||||||
| NEUTROPENIA | 232/657 (35.3%) | 36/269 (13.4%) | 260/938 (27.7%) | |||
| THROMBOCYTOPENIA | 2/657 (0.3%) | 4/269 (1.5%) | 167/938 (17.8%) | |||
| ANAEMIA | 32/657 (4.9%) | 36/269 (13.4%) | 64/938 (6.8%) | |||
| FEBRILE NEUTROPENIA | 36/657 (5.5%) | 3/269 (1.1%) | 4/938 (0.4%) | |||
| Eye disorders | ||||||
| LACRIMATION INCREASED | 53/657 (8.1%) | 49/269 (18.2%) | 45/938 (4.8%) | |||
| Gastrointestinal disorders | ||||||
| DIARRHOEA | 449/657 (68.3%) | 219/269 (81.4%) | 577/938 (61.5%) | |||
| NAUSEA | 350/657 (53.3%) | 190/269 (70.6%) | 625/938 (66.6%) | |||
| STOMATITIS ALL | 419/657 (63.8%) | 57/269 (21.2%) | 195/938 (20.8%) | |||
| VOMITING | 142/657 (21.6%) | 103/269 (38.3%) | 415/938 (44.2%) | |||
| ABDOMINAL PAIN | 118/657 (18%) | 92/269 (34.2%) | 204/938 (21.7%) | |||
| CONSTIPATION | 82/657 (12.5%) | 48/269 (17.8%) | 187/938 (19.9%) | |||
| DYSPEPSIA | 38/657 (5.8%) | 37/269 (13.8%) | 87/938 (9.3%) | |||
| ABDOMINAL PAIN UPPER | 44/657 (6.7%) | 21/269 (7.8%) | 77/938 (8.2%) | |||
| FLATULENCE | 21/657 (3.2%) | 29/269 (10.8%) | 47/938 (5%) | |||
| DRY MOUTH | 23/657 (3.5%) | 14/269 (5.2%) | 26/938 (2.8%) | |||
| General disorders | ||||||
| FATIGUE | 148/657 (22.5%) | 170/269 (63.2%) | 332/938 (35.4%) | |||
| ASTHENIA | 91/657 (13.9%) | 44/269 (16.4%) | 167/938 (17.8%) | |||
| PYREXIA | 60/657 (9.1%) | 43/269 (16%) | 108/938 (11.5%) | |||
| TEMPERATURE INTOLERANCE | 0/657 (0%) | 1/269 (0.4%) | 104/938 (11.1%) | |||
| OEDEMA PERIPHERAL | 22/657 (3.3%) | 29/269 (10.8%) | 51/938 (5.4%) | |||
| CHILLS | 9/657 (1.4%) | 16/269 (5.9%) | 29/938 (3.1%) | |||
| Infections and infestations | ||||||
| NASOPHARYNGITIS | 20/657 (3%) | 15/269 (5.6%) | 32/938 (3.4%) | |||
| UPPER RESPIRATORY TRACT INFECTION | 13/657 (2%) | 18/269 (6.7%) | 29/938 (3.1%) | |||
| URINARY TRACT INFECTION | 14/657 (2.1%) | 20/269 (7.4%) | 22/938 (2.3%) | |||
| Metabolism and nutrition disorders | ||||||
| ANOREXIA | 101/657 (15.4%) | 77/269 (28.6%) | 240/938 (25.6%) | |||
| DEHYDRATION | 24/657 (3.7%) | 33/269 (12.3%) | 68/938 (7.2%) | |||
| HYPOKALAEMIA | 20/657 (3%) | 33/269 (12.3%) | 58/938 (6.2%) | |||
| DECREASED APPETITE | 16/657 (2.4%) | 15/269 (5.6%) | 27/938 (2.9%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| PAIN IN EXTREMITY | 17/657 (2.6%) | 21/269 (7.8%) | 117/938 (12.5%) | |||
| ARTHRALGIA | 22/657 (3.3%) | 26/269 (9.7%) | 41/938 (4.4%) | |||
| BACK PAIN | 14/657 (2.1%) | 25/269 (9.3%) | 46/938 (4.9%) | |||
| PAIN IN JAW | 1/657 (0.2%) | 0/269 (0%) | 55/938 (5.9%) | |||
| Nervous system disorders | ||||||
| PARAESTHESIA | 16/657 (2.4%) | 10/269 (3.7%) | 339/938 (36.1%) | |||
| NEUROPATHY PERIPHERAL | 8/657 (1.2%) | 12/269 (4.5%) | 279/938 (29.7%) | |||
| DYSGEUSIA | 86/657 (13.1%) | 40/269 (14.9%) | 126/938 (13.4%) | |||
| HEADACHE | 46/657 (7%) | 31/269 (11.5%) | 103/938 (11%) | |||
| DIZZINESS | 34/657 (5.2%) | 34/269 (12.6%) | 99/938 (10.6%) | |||
| PERIPHERAL SENSORY NEUROPATHY | 4/657 (0.6%) | 11/269 (4.1%) | 152/938 (16.2%) | |||
| DYSAESTHESIA | 1/657 (0.2%) | 1/269 (0.4%) | 104/938 (11.1%) | |||
| LETHARGY | 46/657 (7%) | 3/269 (1.1%) | 52/938 (5.5%) | |||
| HYPOAESTHESIA | 2/657 (0.3%) | 7/269 (2.6%) | 59/938 (6.3%) | |||
| Psychiatric disorders | ||||||
| INSOMNIA | 49/657 (7.5%) | 38/269 (14.1%) | 78/938 (8.3%) | |||
| ANXIETY | 22/657 (3.3%) | 31/269 (11.5%) | 49/938 (5.2%) | |||
| DEPRESSION | 14/657 (2.1%) | 24/269 (8.9%) | 35/938 (3.7%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 15/657 (2.3%) | 35/269 (13%) | 47/938 (5%) | |||
| OROPHARYNGEAL PAIN | 39/657 (5.9%) | 20/269 (7.4%) | 38/938 (4.1%) | |||
| DYSPNOEA | 15/657 (2.3%) | 16/269 (5.9%) | 63/938 (6.7%) | |||
| EPISTAXIS | 24/657 (3.7%) | 30/269 (11.2%) | 40/938 (4.3%) | |||
| DYSAESTHESIA PHARYNX | 0/657 (0%) | 0/269 (0%) | 93/938 (9.9%) | |||
| RHINORRHOEA | 16/657 (2.4%) | 20/269 (7.4%) | 24/938 (2.6%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | 56/657 (8.5%) | 42/269 (15.6%) | 278/938 (29.6%) | |||
| ALOPECIA | 159/657 (24.2%) | 25/269 (9.3%) | 40/938 (4.3%) | |||
| RASH | 65/657 (9.9%) | 41/269 (15.2%) | 84/938 (9%) | |||
| DRY SKIN | 41/657 (6.2%) | 44/269 (16.4%) | 45/938 (4.8%) | |||
| PRURITUS | 20/657 (3%) | 17/269 (6.3%) | 21/938 (2.2%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann-La Roche |
| Phone | 800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00069121
Other Study ID Numbers:
- NO16968
- NCT00080691
First Posted:
Sep 18, 2003
Last Update Posted:
Mar 6, 2020
Last Verified:
Feb 1, 2020