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Status:

COMPLETED

Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18-74 years

Phase:

PHASE3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from ...

Detailed Description

OBJECTIVES: Primary * Compare the disease-free survival rates in patients with completely resected stage III colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil with...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed stage III adenocarcinoma of the colon
  • Must have undergone curative resection (R0) within the past 28-56 days
  • No radiotherapy prior to surgery
  • carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery
  • No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery
  • No metastatic spread at baseline assessment
  • No prior or concurrent CNS disease by physical exam
  • PATIENT CHARACTERISTICS:
  • Performance status
  • WHO 0-1
  • Life expectancy
  • At least 5 years
  • Hematopoietic
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9 g/dL
  • Hepatic
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 1.5 times ULN
  • Renal
  • Creatinine ≤ 1.5 times ULN
  • Cardiovascular
  • No coronary artery disease
  • No myocardial infarction within the past 12 months
  • No high risk of uncontrolled arrhythmia
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No inflammatory bowel disease
  • No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
  • No significant traumatic injury within the past 28 days
  • No known hypersensitivity to any of the components of the study drugs
  • No medical, geographical, sociological, psychological, or legal condition that would preclude study participation
  • No peripheral neuropathy ≥ grade 1
  • No other significant disease that would preclude study participation
  • PRIOR CONCURRENT THERAPY:
  • Chemotherapy
  • No prior chemotherapy
  • Radiotherapy
  • See Disease Characteristics
  • No prior abdominal or pelvic irradiation
  • Surgery
  • See Disease Characteristics
  • Recovered from prior surgery
  • More than 28 days since prior major surgical procedure or open biopsy
  • No concurrent major surgical procedure

Exclusion

    Key Trial Info

    Start Date :

    November 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 22 2010

    Estimated Enrollment :

    2559 Patients enrolled

    Trial Details

    Trial ID

    NCT00265811

    Start Date

    November 1 2005

    End Date

    June 22 2010

    Last Update

    November 9 2020

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Hopital Duffaut

    Avignon, France, 84902

    2

    CHU de Caen

    Caen, France, 14033

    3

    Hopital Robert Boulin

    Libourne, France, 33500

    4

    Hopital Bichat - Claude Bernard

    Paris, France, 75018