Status:
UNKNOWN
Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping t...
Detailed Description
OBJECTIVES: Primary Objective * To assess whether a 3-month modified FOLFOX 6 or XELOX treatment is not inferior to a 6-month modified FOLFOX 6 or XELOX treatment in terms of disease free survival (...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients who have undergone surgery for colon cancer, defined as a tumor location \>12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum), without gross or microscopic evidence of residual disease after surgery with curative intent.
- Histologically confirmed AJCC/UICC stage III adenocarcinoma colon cancer.
- Age \>18 years.
- Curative surgery and no more than 8 weeks prior to randomization.
- ECOG performance Status (ECOG-PS) \<2.
- Signed written informed consent obtained prior to any study specific procedures.
- CEA ≤ 10 ng/ml (2 X normal value).
- Post-menopausal women or women willing to accept the use of an effective contraceptive regimen during the treatment period and up to 1 month after the end of the study treatment. All non postmenopausal women should have a negative pregnancy test within 72 hours prior to randomization. Men should accept to use an effective contraception during the treatment period, and up to 1 month after the end of the study treatment.
- Registration in a national health care system (CMU included).
- Exclusion criteria:
- Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc").
- Cancer of low or medium rectum with tumor location \< 12 cm from the anal verge by endoscopy.
- Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix).
- Pregnant or lactating women
- Clinically relevant cardiovascular disease (for example: ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy).
- History or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v.3.0.
- Known hypersensitivity reaction to any of the components of study treatments.
- Current or recent (within 28 days prior to randomization) treatment with another investigational drug.
- Subject unwilling or unable to comply with study requirements.
Exclusion
Key Trial Info
Start Date :
May 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00958737
Start Date
May 12 2009
End Date
December 1 2023
Last Update
September 29 2023
Active Locations (1)
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1
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
Paris, France, 75011