Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00551759
Collaborator
National Cancer Institute (NCI) (NIH)
22
109
1
68
0.2
0

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

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study to Measure Response Rate and Toxicity of Neo-adjuvant Chemoradiotherapy With Oxaliplatin (OX) and Infusional 5-Fluorouracil (5-FU) Plus Cetuximab Followed by Post-Operative Docetaxel and Cetuximab in Patients With Operable Adenocarcinoma of the Esophagus
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Feb 1, 2014

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:
  • 5-FU
  • Fluorouracil
  • Adrucil
  • Efudex
  • Drug: Oxaliplatin
    given IV
    Other Names:
  • Trans-l-diaminocyclohexane oxalatoplatinum
  • Cis-[oxalato (trans-I-1,2-diaminocyclohexane) platinum(II)]
  • l-OHP
  • Eloxatin
  • Eloxatine
  • Dacplat
  • 5R96669
  • Drug: Cetuximab
    given IV
    Other Names:
  • Erbitux
  • C225
  • Drug: Docetaxel
    given IV
    Other Names:
  • Taxotere
  • RP 56976
  • 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

    1. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Eastern Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00551759
    Other Study ID Numbers:
    • CDR0000571857
    • U10CA021115
    • E2205
    First Posted:
    Oct 31, 2007
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Eastern Cooperative Oncology Group
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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

    [Not Specified]

    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
    Email
    Responsible Party:
    Eastern Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00551759
    Other Study ID Numbers:
    • CDR0000571857
    • U10CA021115
    • E2205
    First Posted:
    Oct 31, 2007
    Last Update Posted:
    Nov 21, 2017
    Last Verified:
    Oct 1, 2017