Study on the post surgery treatment of patients with curative surgical resection due to colon rectal tumor.
- Conditions
- High-risk stage III colon cancerMedDRA version: 21.0Level: PTClassification code 10038098Term: Rectosigmoid cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-001491-29-IT
- Lead Sponsor
- ICANCER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 640
• Patient =18 years and < 71years
• Patient with ECOG =1
• Pathologically confirmed high-risk stage III colon adenocarcinoma, restricted to pT4N1 or pT1-4N2 tumor.
• Curative R0 surgical resection within 42 days before randomization.
• 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
• Start of study drug treatment has to be performed less than 56 days after surgery.
• No prior chemotherapy.
• No prior abdominal or pelvic irradiation.
• Patient with adequate organ function.
• Adequate contraception if applicable.
• Patient able and willing to comply with study procedures as per protocol
• Patient able to understand and willing to sign and date the written voluntary informed consent form at screening visit prior to any protocol-specific procedures
• Public or private health insurance coverage
• Life expectancy of > or = at 5 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 213
• Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to study treatment start. Incompletely healed wounds or anticipation of the need for major surgical procedure during the course of the study
• Metastatic disease
• Presence of inflammatory bowel disease and/or ileus
• Known hypersensitivity reaction to any of the components of study treatments.
• Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period
• Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QT/QTc =450 msec, for women: QT/QTc =470 msec)
• Previous malignancy in the last 5 years except curative treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent
• History or current evidence on physical examination of central nervous system disease or peripheral neuropathy = grade 1 Common Toxicity Criteria for Adverse Events (CTCAE) v4.03.
• Any significant disease which, in the investigator’s opinion, would exclude the patient from the study.
• Known DPD deficiency or UGT1A1 homozygous 7/7
• Patients already included in another therapeutic trial involving an experimental drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the efficacy comparing mFOLFIRINOX versus mFOLFOX 6 for patients with high-risk stage III colon cancer (pT4N1; pT1-4N2) in terms of 3-year Disease Free Survival rate with an expected gain in DFS of 9% at 3 years (74% versus 65%).;Secondary Objective: • Evaluation of Efficacy: Disease-free-Survival at 2 years.<br>• Overall Survival (OS)<br>• Evaluation of Toxicity;Primary end point(s): The primary end-point is the Disease Free Survival (DFS) at 3 years, defined as the time from the date of randomization up to the date of:<br>- first local, regional or distant relapse;<br>- second colorectal cancer;<br>- death from any cause included treatment-related death.<br>Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS.;Timepoint(s) of evaluation of this end point: 3 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Disease Free Survival at 2 years, defined as the time from the date of randomization up to the date of:<br>- first local, regional or distant relapse<br>- second colorectal cancer<br>- death from any cause included treatment-related death.<br>Other primary cancer (except second primary colorectal) will be ignored. Second primary cancer will be recorded to have the opportunity of evaluating other definition of DFS; Overall Survival (OS) is defined as the time from the date of randomization to the date of documented death from any cause.;Timepoint(s) of evaluation of this end point: 2 years; 9 YEARS AND 6 MONTHS