ADJUVANT TREATMENT OF FULLY RESECTED STAGE III COLON CANCER WITH FOLFOX-4 VERSUS FOLFOX-4 PLUS CETUXIMAB

Phase 1

Conditions: FULLY RESECTED STAGE III COLON CANCER
MedDRA version: 14.1Level: PTClassification code 10010034Term: Colorectal cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2005-003463-23-IT

Lead Sponsor: FFCD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

?Inpatient or outpatient ≥ 18 and < 75 years of age
?Pathologically confirmed stage III colon adenocarcinoma, regardless of the EGFR status, as following
?Curative R0 resection performed within not less than 28 and not more than 56 days prior to randomization
?No prior chemotherapy
?No prior abdominal or pelvic irradiation
?WHO performance status: 0 or 1
?Life expectancy of ≥ 5 years
?Patients with childbearing potential should use effective contraception during the study and the following 6 months
?White blood cell count ≥ 3 x 109/L with neutrophils ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
?Total bilirubin < o pari a 1.5 x ULN (upper limit of normal)
?ASAT and ALAT < o pari a 2.5 x ULN
?Alkaline phosphatase < o pari a 1.5 x ULN
?Serum creatinine < o pari a 1.5 x ULN
?Carcinoembryogenic antigen (CEA) < o pari a 1.5 x ULN after surgery (during screening period)
?Signed written informed consent obtained prior to any study specific screening procedures
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

?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 spread at baseline assessment
?Rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery or having received radiation therapy prior to surgery
?Presence of inflammatory bowel disease
?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
?Previous malignancy other than CRC in the last 5 years except 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) v.3.0
?Any significant disease which, in the investigator's opinion, would exclude the patient from the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess and to compare the disease free survival curves;Secondary Objective: ?3-year disease-free survival <br>?Overall Survival <br>?5-year overall Survival <br>?Treatment compliance<br>?Identification of prognostic factors<br>?Safety<br>?Markers predictive for relapse and/or treatment efficacy;Primary end point(s): The primary target variable is disease free survival (DFS). DFS is defined as the interval from randomization to locoregional or metastatic recurrence or the appearance of a secondary colorectal cancer or death, whichever occurs first. Patients who are alive and without recurrence or secondary colorectal cancer at the time of cut-off will be right-censored at the most recent date of assessment. Recurrence may be either histologically proven or evidenced by imaging. Isolated CEA elevation will not be sufficient to determine a relapse

Secondary Outcome Measures

Name	Time	Method