A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer
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 (DFS) in
patients with radically resected stage III colon cancer.
Secondary Objectives
- To assess whether 3-month modified FOLFOX 6 (6 cycles) or XELOX (4 cycles) treatment is
not inferior to 6-month modified FOLFOX 6 (12 cycles) or XELOX (8 cycles) treatment in
terms of overall survival (OS) in patients with radically resected stage III colon
cancer
- To evaluate the safety profiles of the treatment groups
Tertiary Objectives
- For patients who signed a specific informed consent, blood and tumour tissue samples
will be stored, registered, and centralized in a data bank for translational research
projects that will be further determined according to the literature and scientific
knowledge at the time of the end of inclusion. (exploratory)
- An economic evaluation at the country level will be conducted alongside the clinical
evaluation. (exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to center, T stage
(1 or 2 vs 3 vs 4), N stage (1 vs 2), performance status (0 vs 1 vs 2), and age (< 70 years
vs ≥ 70 years). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive modified FOLFOX 6 comprising oxaliplatin IV over 2 hours,
leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.
Treatment repeats every 14 days for 6 courses (3 months).
- Arm II: Patients receive modified FOLFOX 6 as in arm I. Treatment repeats every 14 days
for 12 courses (6 months).
Blood and tumor samples may be collected at baseline for pharmacogenetic and other analyses.
After completion of study treatment, patients are followed up every 6 months for 8 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed colon cancer
- Tumor location > 12 cm from the anal verge by endoscopy and/or above the
peritoneal reflection at surgery (high rectum)
- AJCC/UICC stage III disease
- Adenocarcinoma
- No evidence of metastatic disease (including presence of tumor cells in ascites
or peritoneal carcinomatosis resected "en bloc")
- Undergone curative surgery for colon cancer within the past 8 weeks
- No gross, macroscopic, or microscopic evidence of residual disease (R1 or R2
resections) after surgery
- Carcinoembryonic antigen ≤ 10 ng/mL (2 times normal)
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and up to 1 month after
completion of study treatment
- Willing and able to comply with study requirements
- No clinically relevant cardiovascular disease (ischemic myocardial infarction in the
past year and/or unstable ischemic cardiopathy)
- No other malignancies within the past 5 years except for curatively treated basal
cell carcinoma of the skin and/or in situ carcinoma of the cervix
- No history or current evidence on physical examination of central nervous system
disease or peripheral neuropathy ≥ CTCAE v.3.0 grade 1
- No known hypersensitivity reaction to any of the components of study treatments
- Registered in a national health care system (CMU included)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 28 days since prior treatment, no concurrent treatment, and no treatment
while the patient is disease-free during study follow-up with another investigational
drug
- No concurrent treatment or treatment while the patient is disease-free during study
follow-up with other cytotoxic agents, or active or passive immunotherapy for colon
cancer
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival (defined as local, regional, or distant relapse; second primary colorectal cancer; or death from any cause)
Outcome Time Frame:
3 years after randomisation
Safety Issue:
No
Principal Investigator
Thierry Andre, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
CDR0000647466
NCT ID:
NCT00958737
Start Date:
April 2009
Completion Date:
September 2017
Related Keywords:
- Colorectal Cancer
- stage III colon cancer
- adenocarcinoma of the colon
- Colonic Neoplasms
- Colorectal Neoplasms
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