Colectomy in Patients With Asymptomatic and Unresectable Stage IV Colon Cancer

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study is a multicentric randomized phase III trial designed to assess whether overall survival and quality of life are improved in patients with asymptomatic colon cancer and unresectable SLM treated with resection of the PT followed by chemotherapy versus chemotherapy alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Federation Francophone de Cancerologie Digestive; GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR); UNICANCER

Criteria

Inclusion criteria :

• Pathologically confirmed colon adenocarcinoma (≥ 15 cm from the anal verge)

• Uncomplicated PT (obstruction, bleeding, abcess, perforation)

• No known unresectable PT on CT/MRI scan.

• Unresectable synchronous liver metastases

• No extra-hepatic metastatic disease

• Age ≥ 18 years et ≤ 75 years

• ECOG performance status 0-1

• Life expectancy without cancer >2 years

• No prior chemotherapy in the past 5 years

• No prior abdominal or pelvic irradiation

• No history of colorectal cancer in the past 5years

• 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 x109/L, hemoglobin ≥ 9 g/dL (5,6 mmol/l)

• Total bilirubin <1.5 x ULN (upper limit of normal), ASAT and ALAT<2.5 x ULN, Alkaline phosphatase<1.5 x ULN, Serum creatinine < 1.5 x ULN

• Signed written informed consent obtained prior to any study specific screening procedures

Exclusion criteria :

• Resectable or potentially resectable liver metastases

• Complicated (obstruction, bleeding, abcess, perforation) or non resectable PT

• 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

• Age > 75 years

• ECOG performance status > 2

• Denutrition (albumin < 30 g/l)

• Synchronous colorectal cancer

• Extrahepatic metastatic disease

• Known hypersensitivity reaction or specific contraindications to any of the components of study treatments

• History of anti-EGFR or anti-VEGF treatment within the past 5 years

• 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

• Presence of inflammatory bowel disease

• HNPCC syndrome or polyposis

• 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

• Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia

• Pregnancy (absence to be confirmed by ß-hCG test) or breast-feeding period

• Previous malignancy in the last 5 years

• Medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent

• Any significant disease which, in the investigator's opinion, would exclude the patient from the study