Colectomy in Patients With Asymptomatic and Unresectable Stage IV Colon Cancer

NCT02363049 | Unknown Phase 3

• 1 other identifier: 2013-A00685-40
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm of Large Intestine; Colon Cancer Liver Metastasis

Keywords

Colectomy; primary tumor resection; Asymptomatic primary colon cancer; Unresectable synchronous liver metastasis; TNM Staging Primary Tumor (T); Unresectable

Outcome Measures

Primary Outcomes (1)

• overall survival

  2 years

Secondary Outcomes (5)

• quality of life

  2 years

• Post-operative complications

  30 days

• Progression free survival (PFS)

  2 years

• Time to metastatic progression (TTP)

  2 years

• Rate of secondary curative resection (R0)

  1 year

Study Arms (2)

colectomy

EXPERIMENTAL

surgery followed by chemotherapy +/- targeted therapy regime according to each centre

Procedure: Colectomy; Drug: Chemotherapy

no colectomy

ACTIVE COMPARATOR

Chemotherapy +/- targeted therapy alone, regime according to each centre.

Drug: Chemotherapy

Interventions

Colectomy PROCEDURE

colectomy

Chemotherapy DRUG

colectomy; no colectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• UNICANCER: collaborator
• Federation Francophone de Cancerologie Digestive: collaborator
• GERCOR - Multidisciplinary Oncology Cooperative Group: collaborator

Study Sites (1)

Groupe hospitalier Pitié Salpetriere

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colectomy; Drug Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Mehdi Karoui, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehdi Karoui, MD, PhD

CONTACT

+331-42-17-56-51

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: July 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (1)