Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer (IDEA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Sponsor:
Information provided by (Responsible Party):
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier:
NCT00958737
First received: August 12, 2009
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given for 3 months or 6 months in treating patients with colon cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy for 3 months to see how well it works compared with giving combination chemotherapy for 6 months in treating patients with stage III colon cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: FOLFOX regimen
Drug: fluorouracil
Drug: leucovorin calcium
Drug: oxaliplatin
Drug: XELOX regimen
Drug: Capecitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial Investigating the Duration of Adjuvant Therapy(3 Versus 6 Months) With the Modified FOLFOX 6 or XELOX Regimens for Patients With Stage III Colon Cancer

Resource links provided by NLM:


Further study details as provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):

Primary Outcome Measures:
  • Disease-free survival (defined as local, regional, or distant relapse; second primary colorectal cancer; or death from any cause) [ Time Frame: 3 years after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: death from randomization ] [ Designated as safety issue: No ]
  • Toxicity according to NCI CTCAE version 3.0 [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]
  • Total cumulative dose received vs planned dose [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
  • Incidence and timing of dose reductions and/or modifications of time [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

Patients receive modified FOLFOX 6 comprising oxaliplatin IV 85 mg/m² over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 14 days for 6 courses (3 months).

Patients receive XELOX comprising oxaliplatin IV 130 mg/m² over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which will be administered orally at a dose of 1000 mg/m2 twice-daily (equivalent to a total daily dose of 2000 mg/m2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment)

Drug: FOLFOX regimen
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Drug: XELOX regimen Drug: Capecitabine
oral
Experimental: Arm II
Patients receive modified FOLFOX 6 or XELOX as in arm I. Treatment repeats every 14 days for 12 courses (6 months)or regarding XELOX every 21 days for 8 courses (6 month).
Drug: FOLFOX regimen
Given IV
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Drug: XELOX regimen Drug: Capecitabine
oral

Detailed Description:

OBJECTIVES:

Primary Objective

  • To assess whether a 3-month modified FOLFOX 6 or XELOX treatment is not inferior to a 6-month modified FOLFOX 6 or XELOX treatment in terms of disease free survival (DFS) in patients with radically resected stage III colon cancer.

Secondary Objectives

  • To assess whether 3-month modified FOLFOX 6 (6 cycles) or XELOX (4 cycles) treatment is not inferior to 6-month modified FOLFOX 6 (12 cycles) or XELOX (8 cycles) treatment in terms of overall survival (OS) in patients with radically resected stage III colon cancer
  • To evaluate the safety profiles of the treatment groups

Tertiary Objectives

  • For patients who signed a specific informed consent, blood and tumour tissue samples will be stored, registered, and centralized in a data bank for translational research projects that will be further determined according to the literature and scientific knowledge at the time of the end of inclusion. (exploratory)
  • An economic evaluation at the country level will be conducted alongside the clinical evaluation. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to center, T stage (1 or 2 vs 3 vs 4), N stage (1 vs 2), performance status (0 vs 1 vs 2), and age (< 70 years vs ≥ 70 years). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive modified FOLFOX 6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1. Treatment repeats every 14 days for 6 courses (3 months).
  • Arm II: Patients receive modified FOLFOX 6 as in arm I. Treatment repeats every 14 days for 12 courses (6 months).

Blood and tumor samples may be collected at baseline for pharmacogenetic and other analyses.

After completion of study treatment, patients are followed up every 6 months for 8 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colon cancer

    • Tumor location > 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery (high rectum)
    • AJCC/UICC stage III disease
    • Adenocarcinoma
    • No evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")
  • Undergone curative surgery for colon cancer within the past 8 weeks

    • No gross, macroscopic, or microscopic evidence of residual disease (R1 or R2 resections) after surgery
  • Carcinoembryonic antigen ≤ 10 ng/mL (2 times normal)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and up to 1 month after completion of study treatment
  • Willing and able to comply with study requirements
  • No clinically relevant cardiovascular disease (ischemic myocardial infarction in the past year and/or unstable ischemic cardiopathy)
  • No other malignancies within the past 5 years except for curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  • No history or current evidence on physical examination of central nervous system disease or peripheral neuropathy ≥ CTCAE v.3.0 grade 1
  • No known hypersensitivity reaction to any of the components of study treatments
  • Registered in a national health care system (CMU included)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 28 days since prior treatment, no concurrent treatment, and no treatment while the patient is disease-free during study follow-up with another investigational drug
  • No concurrent treatment or treatment while the patient is disease-free during study follow-up with other cytotoxic agents, or active or passive immunotherapy for colon cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00958737

Locations
France
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie Recruiting
Paris, France, 75011
Contact: Thierry Andre, MD    33-1-71-97-03-87    thierry.andre@sat.aphp.fr   
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Principal Investigator: Thierry Andre, MD Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
ClinicalTrials.gov Identifier: NCT00958737     History of Changes
Other Study ID Numbers: CDR0000647466, FRE-GERCOR-C09-1-IDEA, EUDRACT-2009-010384-16, EU-20957
Study First Received: August 12, 2009
Last Updated: November 6, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR):
stage III colon cancer
adenocarcinoma of the colon

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Capecitabine
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 20, 2014