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

Colorectal Cancer Clinical Trial

— IDEA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00958737
• Other study ID #: IDEA-C09-1
• Secondary ID: 2009-010384-16EU
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 12, 2009
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: GERCOR - Multidisciplinary Oncology Cooperative Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2023
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 postmenopausal 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).

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").

• Cancer of low or medium rectum with tumor location < 12 cm from the anal verge by endoscopy.

• 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 (for example: 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.

• Subject unwilling or unable to comply with study requirements.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer

Intervention

Drug:
• FOLFOX regimen
6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6))
• CAPOX
4 or 8 cycles

Locations

Country	Name	City	State
France	GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

References & Publications (1)

Andre T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, Fratte S, Hug de Larauze M, Paget-Bailly S, Chibaudel B, Bez J, Dauba J, Louvet C, Lepere C, Dupuis O, Becouarn Y, Mabro M, Egreteau J, Bouche O, Deplanque G, Ychou M, Galais MP, Ghiringhelli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS)	DFS, defined as the time from random assignment to relapse or death, whichever occurred first. Secondary colorectal cancers were regarded as DFS events, whereas noncolorectal cancers were disregarded in the analysis.	3 years after randomisation
Secondary	Overall survival (OS)	The time from the date of randomization to the date of death from any cause	Death from randomization; up to 7 years after randomization
Secondary	Safety profile	All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0	Assessed up to 6 months after randomisation
Secondary	Treatment compliance	duration, dose intensity, and dose in mg/m2	Until 3 months or 6 months (according randomization arm)

External Links

•   IDEA France phase III trial