Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving docetaxel and cetuximab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with cetuximab followed by surgery, docetaxel and cetuximab works in treating patients with esophageal cancer or gastroesophageal junction cancer.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To determine the pathologic complete response (pCR) rate of neoadjuvant chemoradiotherapy with OX/5-FU/radiotherapy (RT) plus cetuximab in patients with resectable adenocarcinoma of the esophagus.
Secondary
-
To evaluate the safety of neoadjuvant chemoradiotherapy with OX/5-FU/RT plus cetuximab in patients with resectable adenocarcinoma of the esophagus.
-
To evaluate the safety and tolerability of adjuvant therapy comprising cetuximab and docetaxel in these patients.
-
To carry out exploratory studies to determine if activity of this regimen correlates with epidermal growth factor receptor (EGFR)-related genetic and pathway activation markers and circulating endothelial and tumor cells.
OUTLINE: This is a multicenter study.
-
Neoadjuvant chemoradiotherapy and cetuximab: Patients receive oxaliplatin intravenously (IV) over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV continuously over 24 hours on days 1-35. Patients also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients then proceed to surgery.
-
Surgery: Patients undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Patients with an R0 or R1 resection proceed to adjuvant therapy. Patients whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.
-
Adjuvant therapy: Within 4-8 weeks after surgery, patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, and then every 6 months for 3-5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Neoadjuvant therapy, Surgery, adjuvant therapy Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. |
Drug: 5-Fluorouracil
given IV
Other Names:
Drug: Oxaliplatin
given IV
Other Names:
Drug: Cetuximab
given IV
Other Names:
Drug: Docetaxel
given IV
Other Names:
Procedure: Surgery
Patients underwent surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab.
Radiation: Radiotherapy
Patients underwent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33.
|
Outcome Measures
Primary Outcome Measures
- Proportion of Patients With Pathologic Complete Response [At time of surgery (which occurred 63 to 91 days after study entry)]
After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Newly diagnosed adenocarcinoma of the esophagus (> 20 cm below the incisors) or gastroesophageal (GE) junction, untreated with chemotherapy, radiation therapy, and surgery. Endoscopy with biopsy and dilation was permitted.
-
Tumor stage T2N0M0, T3N0M0, T1-3N+M0, or T1-3N0-1M1A as determined by imaging studies performed no greater than 4 weeks prior to registration, and biopsy, where appropriate. Celiac nodal metastasis (M1A disease) was permitted if other eligibility criteria were met. Data from endoscopic ultrasound and endoscopy were required for staging. The following imaging was required: CT scan with IV contrast and PET or PET+CT. If the PET/CT incorporates CT with IV contrast, then a separate CT is not required. If laparoscopy or other relevant procedures were performed, the data were to be incorporated into stage assignment. Any lesion suspicious for metastasis had to have been biopsied to prove eligibility.
-
Tumor extension into cardia, if present, must have been no more than 2 cm.
-
Tumors must have been considered surgically resectable (T1-3, not T4).
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Granulocytes > 1,000/ mm³
-
Platelets > 100,000 μL
-
Creatinine normal or creatinine clearance > 60 mL/min
-
Total serum bilirubin < 1.5 mg/dL
-
Fertile patients must use effective contraception
-
History of a curatively treated malignancy from which the patient has been disease-free for ≥ 2 years and has a survival prognosis of > 5 years
Exclusion Criteria:
-
Pregnant or breast-feeding.
-
Prior severe infusion reaction to a monoclonal antibody
-
prior therapy specifically and directly targeting the epidermal growth factor receptor (EGFR) pathway
-
Hypertension
-
Uncontrolled diabetes
-
Intercurrent illness that would likely interfere with protocol therapy or prevent surgical resection
-
Any of the following within the past 6 months:
-
New York Heart Association class III-IV congestive heart failure
-
Cerebrovascular accident or transient ischemic attack
-
Unstable angina or myocardial infarction
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
2 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
3 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60504 |
4 | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | United States | 60611-3013 |
5 | Hematology and Oncology Associates | Chicago | Illinois | United States | 60611 |
6 | Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | United States | 62526 |
7 | Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | United States | 60521 |
8 | Midwest Center for Hematology/Oncology | Joliet | Illinois | United States | 60432 |
9 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
10 | North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | United States | 60048 |
11 | La Grange Oncology Associates - Geneva | Naperville | Illinois | United States | 60563 |
12 | Cancer Care and Hematology Specialists of Chicagoland - Niles | Niles | Illinois | United States | 60714 |
13 | Swedish-American Regional Cancer Center | Rockford | Illinois | United States | 61104-2315 |
14 | Hematology Oncology Associates - Skokie | Skokie | Illinois | United States | 60076 |
15 | Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | United States | 62781-0001 |
16 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
17 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
18 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
19 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
20 | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | United States | 52403 |
21 | Mercy Capitol Hospital | Des Moines | Iowa | United States | 50307 |
22 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
23 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
24 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
25 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
26 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
27 | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
28 | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa | United States | 50401 |
29 | McCreery Cancer Center at Ottumwa Regional | Ottumwa | Iowa | United States | 52501 |
30 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
31 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
32 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
33 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
34 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
35 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
36 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
37 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
38 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
39 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
40 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
41 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
42 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
43 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
44 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
45 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67208 |
46 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
47 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
48 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
49 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
50 | Wesley Medical Center | Wichita | Kansas | United States | 67214 |
51 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
52 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
53 | Union Hospital Cancer Program at Union Hospital | Elkton | Maryland | United States | 21921 |
54 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
55 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49001 |
56 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007-3731 |
57 | Bronson Methodist Hospital | Kalamazoo | Michigan | United States | 49007 |
58 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
59 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
60 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
61 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
62 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
63 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
64 | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
65 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
66 | Park Nicollet Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
67 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
68 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
69 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
70 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
71 | Cancer Resource Center - Lincoln | Lincoln | Nebraska | United States | 68510 |
72 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
73 | Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
74 | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
75 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131-2197 |
76 | Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton | New Jersey | United States | 08053 |
77 | Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown | New Jersey | United States | 07962 |
78 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
79 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
80 | Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees | New Jersey | United States | 08043 |
81 | Our Lady of Mercy Medical Center Comprehensive Cancer Center | The Bronx | New York | United States | 10466 |
82 | Summa Center for Cancer Care at Akron City Hospital | Akron | Ohio | United States | 44309-2090 |
83 | Mercy Cancer Center at Mercy Medical Center | Canton | Ohio | United States | 44708 |
84 | Aultman Cancer Center at Aultman Hospital | Canton | Ohio | United States | 44710-1799 |
85 | St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | United States | 18015 |
86 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
87 | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301-1792 |
88 | Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | United States | 19107-5541 |
89 | UPMC Cancer Centers | Pittsburgh | Pennsylvania | United States | 15232 |
90 | Pottstown Memorial Regional Cancer Center | Pottstown | Pennsylvania | United States | 19464 |
91 | McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading | Pennsylvania | United States | 19612-6052 |
92 | Hematology and Oncology Associates of Northeastern Pennsylvania | Scranton | Pennsylvania | United States | 18508 |
93 | CCOP - Main Line Health | Wynnewood | Pennsylvania | United States | 19096 |
94 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
95 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
96 | Medical X-Ray Center, PC | Sioux Falls | South Dakota | United States | 57105 |
97 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
98 | Center for Cancer Treatment & Prevention at Sacred Heart Hospital | Eau Claire | Wisconsin | United States | 54701 |
99 | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin | United States | 54701 |
100 | Gundersen Lutheran Center for Cancer and Blood | La Crosse | Wisconsin | United States | 54601 |
101 | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin | United States | 54449 |
102 | Saint Joseph's Hospital | Marshfield | Wisconsin | United States | 54449 |
103 | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin | United States | 54548 |
104 | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin | United States | 54501 |
105 | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin | United States | 54868 |
106 | Saint Michael's Hospital Cancer Center | Stevens Point | Wisconsin | United States | 54481 |
107 | Marshfield Clinic - Wausau Center | Wausau | Wisconsin | United States | 54401 |
108 | Marshfield Clinic - Weston Center | Weston | Wisconsin | United States | 54476 |
109 | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin | United States | 54494 |
Sponsors and Collaborators
- Eastern Cooperative Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Michael K. Gibson, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000571857
- U10CA021115
- E2205
Study Results
Participant Flow
Recruitment Details | Participants were recruited from ECOG member institutions between June 10, 2008 and January 8, 2010. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
---|---|
Arm/Group Description | Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. |
Period Title: Overall Study | |
STARTED | 22 |
Eligible and Began Treatment | 21 |
Underwent Surgery | 17 |
Received Adjuvant Therapy | 12 |
COMPLETED | 9 |
NOT COMPLETED | 13 |
Baseline Characteristics
Arm/Group Title | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
---|---|
Arm/Group Description | Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. |
Overall Participants | 21 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
62
|
Sex: Female, Male (Count of Participants) | |
Female |
2
9.5%
|
Male |
19
90.5%
|
Outcome Measures
Title | Proportion of Patients With Pathologic Complete Response |
---|---|
Description | After neoadjuvant therapy, participants underwent surgical resection. The excised tumor was examined by a pathologist. A pathologic complete response is defined as the absence of any histopathologic evidence of tumor in the resected esophageal and nodal tissue specimen. |
Time Frame | At time of surgery (which occurred 63 to 91 days after study entry) |
Outcome Measure Data
Analysis Population Description |
---|
Eligible and treated patients |
Arm/Group Title | Neoadjuvant Therapy, Surgery, Adjuvant Therapy |
---|---|
Arm/Group Description | Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery. Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician. Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. |
Measure Participants | 21 |
Number (90% Confidence Interval) [Proportion of patients] |
0.33
|
Adverse Events
Time Frame | Assessed every 6 weeks while on treatment and for 30 days after the end of treatment | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Neoadjuvant Therapy, Surgery, Adjuvant Therapy | |
Arm/Group Description | 35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab. | |
All Cause Mortality |
||
Neoadjuvant Therapy, Surgery, Adjuvant Therapy | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
Neoadjuvant Therapy, Surgery, Adjuvant Therapy | ||
Affected / at Risk (%) | # Events | |
Total | 19/22 (86.4%) | |
Blood and lymphatic system disorders | ||
Anemia | 4/22 (18.2%) | |
Thrombotic microangiopathy | 1/22 (4.5%) | |
Cardiac disorders | ||
Heart block asystole | 1/22 (4.5%) | |
Atrial fibrillation | 1/22 (4.5%) | |
Gastrointestinal disorders | ||
Constipation | 1/22 (4.5%) | |
Diarrhea w/o prior colostomy | 4/22 (18.2%) | |
Distention/bloating, abdominal | 1/22 (4.5%) | |
Dysphagia | 3/22 (13.6%) | |
Esophagitis | 5/22 (22.7%) | |
Malabsorption | 1/22 (4.5%) | |
Muco/stomatitis (symptom) esophagus | 3/22 (13.6%) | |
Nausea | 5/22 (22.7%) | |
Necrosis, small bowel NOS | 1/22 (4.5%) | |
Perforation, colon | 1/22 (4.5%) | |
Stenosis (incl anastomotic) esophagus | 1/22 (4.5%) | |
Vomiting | 2/22 (9.1%) | |
Abdomen, pain | 1/22 (4.5%) | |
Esophagus, pain | 1/22 (4.5%) | |
General disorders | ||
Fatigue | 5/22 (22.7%) | |
Death - multiorgan failure | 1/22 (4.5%) | |
Immune system disorders | ||
Allergic reaction | 1/22 (4.5%) | |
Infections and infestations | ||
Infection Gr0-2 neut, brain | 1/22 (4.5%) | |
Infection Gr0-2 neut, colon | 1/22 (4.5%) | |
Infection Gr0-2 neut, lung | 1/22 (4.5%) | |
Infection Gr0-2 neut, sm bowel | 1/22 (4.5%) | |
Infection w/ unk ANC wound | 2/22 (9.1%) | |
Infection Gr0-2 neut, blood | 2/22 (9.1%) | |
Injury, poisoning and procedural complications | ||
Radiation dermatitis | 1/22 (4.5%) | |
Surgical hemorrhage | 1/22 (4.5%) | |
Vascular access,Thrombosis/embolism | 1/22 (4.5%) | |
Investigations | ||
Leukocytes decreased | 2/22 (9.1%) | |
Lymphopenia | 5/22 (22.7%) | |
Neutrophils decreased | 1/22 (4.5%) | |
Platelets decreased | 2/22 (9.1%) | |
Cardiac troponin I (cTnI) increased | 1/22 (4.5%) | |
Weight loss | 1/22 (4.5%) | |
Activated partial thromboplastin time pr | 1/22 (4.5%) | |
Coagulation-other | 2/22 (9.1%) | |
Alkaline phosphatase increased | 1/22 (4.5%) | |
Metabolism and nutrition disorders | ||
Anorexia | 5/22 (22.7%) | |
Dehydration | 8/22 (36.4%) | |
Hypoalbuminemia | 3/22 (13.6%) | |
Hypocalcemia | 4/22 (18.2%) | |
Hyperglycemia | 1/22 (4.5%) | |
Hypomagnesemia | 1/22 (4.5%) | |
Hypophosphatemia | 1/22 (4.5%) | |
Hypokalemia | 2/22 (9.1%) | |
Hyponatremia | 2/22 (9.1%) | |
Musculoskeletal and connective tissue disorders | ||
Nonneuropathic generalized weakness | 1/22 (4.5%) | |
Nervous system disorders | ||
Laryngeal nerve dysfunction | 1/22 (4.5%) | |
Neuropathy-motor | 1/22 (4.5%) | |
Depressed level of consciousness | 1/22 (4.5%) | |
Syncope | 1/22 (4.5%) | |
Respiratory, thoracic and mediastinal disorders | ||
(ARDS) | 4/22 (18.2%) | |
Dyspnea | 2/22 (9.1%) | |
Hiccoughs | 1/22 (4.5%) | |
Hypoxia | 4/22 (18.2%) | |
Pleural effusion (non-malignant) | 2/22 (9.1%) | |
Pneumonitis/pulmonary infiltrates | 2/22 (9.1%) | |
Pulmonary/Upper Respiratory-other | 1/22 (4.5%) | |
Skin and subcutaneous tissue disorders | ||
Rash/desquamation | 1/22 (4.5%) | |
Rash: acne/acneiform | 1/22 (4.5%) | |
Vascular disorders | ||
Hypotension | 2/22 (9.1%) | |
Thrombosis/thrombus/embolism | 3/22 (13.6%) | |
Other (Not Including Serious) Adverse Events |
||
Neoadjuvant Therapy, Surgery, Adjuvant Therapy | ||
Affected / at Risk (%) | # Events | |
Total | 22/22 (100%) | |
Blood and lymphatic system disorders | ||
Anemia | 16/22 (72.7%) | |
Cardiac disorders | ||
Palpitations | 2/22 (9.1%) | |
Gastrointestinal disorders | ||
Constipation | 8/22 (36.4%) | |
Diarrhea w/o prior colostomy | 11/22 (50%) | |
Dysphagia | 3/22 (13.6%) | |
Esophagitis | 3/22 (13.6%) | |
Dyspepsia | 4/22 (18.2%) | |
Muco/stomatitis (symptom) esophagus | 10/22 (45.5%) | |
Nausea | 15/22 (68.2%) | |
Salivary | 3/22 (13.6%) | |
Vomiting | 11/22 (50%) | |
Abdomen, pain | 2/22 (9.1%) | |
Esophagus, pain | 4/22 (18.2%) | |
General disorders | ||
Fatigue | 18/22 (81.8%) | |
Fever w/o neutropenia | 5/22 (22.7%) | |
Edema limb | 2/22 (9.1%) | |
Chest/thoracic pain NOS | 2/22 (9.1%) | |
Injury, poisoning and procedural complications | ||
Radiation dermatitis | 5/22 (22.7%) | |
Investigations | ||
Leukocytes decreased | 5/22 (22.7%) | |
Lymphopenia | 3/22 (13.6%) | |
Neutrophils decreased | 6/22 (27.3%) | |
Platelets decreased | 9/22 (40.9%) | |
Weight loss | 10/22 (45.5%) | |
Alkaline phosphatase increased | 2/22 (9.1%) | |
Alanine aminotransferase increased | 3/22 (13.6%) | |
Aspartate aminotransferase increased | 3/22 (13.6%) | |
Metabolism and nutrition disorders | ||
Anorexia | 10/22 (45.5%) | |
Dehydration | 3/22 (13.6%) | |
Hypoalbuminemia | 7/22 (31.8%) | |
Acidosis | 2/22 (9.1%) | |
Hypocalcemia | 10/22 (45.5%) | |
Hyperglycemia | 3/22 (13.6%) | |
Hypomagnesemia | 7/22 (31.8%) | |
Hypokalemia | 6/22 (27.3%) | |
Hyponatremia | 4/22 (18.2%) | |
Nervous system disorders | ||
Taste disturbance | 2/22 (9.1%) | |
Dizziness | 3/22 (13.6%) | |
Neuropathy-motor | 3/22 (13.6%) | |
Neuropathy-sensory | 11/22 (50%) | |
Head/headache | 4/22 (18.2%) | |
Psychiatric disorders | ||
Insomnia | 3/22 (13.6%) | |
Depression | 3/22 (13.6%) | |
Respiratory, thoracic and mediastinal disorders | ||
Nose, hemorrhage | 2/22 (9.1%) | |
Atelectasis | 3/22 (13.6%) | |
Cough | 6/22 (27.3%) | |
Dyspnea | 4/22 (18.2%) | |
Pleural effusion (non-malignant) | 4/22 (18.2%) | |
Voice changes/dysarthria | 3/22 (13.6%) | |
Skin and subcutaneous tissue disorders | ||
Dry skin | 6/22 (27.3%) | |
Alopecia | 3/22 (13.6%) | |
Nail changes | 2/22 (9.1%) | |
Rash/desquamation | 5/22 (22.7%) | |
Rash: acne/acneiform | 9/22 (40.9%) | |
Hand-foot reaction | 8/22 (36.4%) | |
Vascular disorders | ||
Hypotension | 2/22 (9.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Study Statistician |
---|---|
Organization | ECOG Statistical Office |
Phone | 617-632-3012 |
- CDR0000571857
- U10CA021115
- E2205