A Phase III randomized trial investigating the duration of adjuvant therapy with the modified FOLFOX 6 regimen (3 versus 6 months) for patients with stage III colon cancer. - IDEA

Conditions: Stage III colon cancer
MedDRA version: 9.1Level: LLTClassification code 10009955Term: Colon cancer stage III

Registration Number: EUCTR2009-010384-16-FR

Lead Sponsor: GERCOR

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 post-menopausal 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)

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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”)
•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 (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 or participation in another investigational study
•Subject unwilling or unable to comply with study requirements