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

NCT00958737 | Unknown Phase 3

• 3 other identifiers: IDEA-C09-12009-010384-16EU-20957
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

stage III colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival (OS)

  Death from randomization; up to 7 years after randomization

• Safety profile

  Assessed up to 6 months after randomisation

• Treatment compliance

  Until 3 months or 6 months (according randomization arm)

Study Arms (2)

Arm I

EXPERIMENTAL

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 CAPOX 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; Drug: CAPOX

Arm II

EXPERIMENTAL

Patients receive modified FOLFOX 6 or CAPOX as in arm I. Treatment repeats every 14 days for 12 courses (6 months)or regarding CAPOX every 21 days for 8 courses (6 month).

Drug: FOLFOX regimen; Drug: CAPOX

Interventions

FOLFOX regimen DRUG

6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6))

Also known as: folinic acid, infusional fluorouracil, and oxaliplatin

Arm I; Arm II

CAPOX DRUG

4 or 8 cycles

Also known as: capecitabine plus oxaliplatin; XELOX

Arm I; Arm II

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (1)

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Paris, 75011, France

Location

Related Publications (5)

• 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 F, Dourthe LM, Bachet JB, Khalil A, Bonnetain F, de Gramont A, Taieb J; for PRODIGE investigators, GERCOR, Federation Francaise de Cancerologie Digestive, and UNICANCER. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

  PMID: 29620995 RESULT

• Taieb J, Souglakos J, Boukovinas I, Falcoz A, Pages F, Messaritakis I, Bennouna J, Artru P, Louvet C, Lepere C, Emile JF, Bouche O, Mazard T, Vernerey D, Vogiatzoglou K, Tzardi M, Sharma S, Liu MC, Sethi H, Andre T, Galon J, Laurent-Puig P. Combined Analyses of Circulating Tumor DNA and Immunoscore in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the PRODIGE-GERCOR IDEA-France/HORG-IDEA-Greece Trials. J Clin Oncol. 2025 May;43(13):1564-1577. doi: 10.1200/JCO.24.00648. Epub 2025 Feb 4.

  PMID: 39903903 DERIVED

• Gallois C, Sroussi M, Andre T, Mouillet-Richard S, Agueeff N, Mulot C, Vernerey D, Louvet C, Bachet JB, Dourthe LM, Mazard T, Jary M, Coutzac C, Lecaille C, Tabernero J, Van Laethem JL, Lepage C, Emile JF, de Reynies A, Taieb J, Laurent-Puig P. Prognostic Models From Transcriptomic Signatures of the Tumor Microenvironment and Cell Cycle in Stage III Colon Cancer From PETACC-8 and IDEA-France Trials. J Clin Oncol. 2025 May 20;43(15):1765-1776. doi: 10.1200/JCO.23.02262. Epub 2025 Jan 31.

  PMID: 39889251 DERIVED

• Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

  PMID: 36306483 DERIVED

• Delattre JF, Cohen R, Henriques J, Falcoz A, Emile JF, Fratte S, Chibaudel B, Dauba J, Dupuis O, Becouarn Y, Bibeau F, Taieb J, Louvet C, Vernerey D, Andre T, Svrcek M. Prognostic Value of Tumor Deposits for Disease-Free Survival in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the IDEA France Phase III Trial (PRODIGE-GERCOR). J Clin Oncol. 2020 May 20;38(15):1702-1710. doi: 10.1200/JCO.19.01960. Epub 2020 Mar 13.

  PMID: 32167864 DERIVED

Related Links

• IDEA France phase III trial

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Folfox protocol; Leucovorin; Oxaliplatin; Capecitabine; XELOX

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Thierry Andre, MD

  GERCOR - Multidisciplinary Oncology Cooperative Group

  PRINCIPAL INVESTIGATOR

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: August 12, 2009
• First Posted: August 13, 2009
• Study Start: May 12, 2009
• Primary Completion: January 1, 2020
• Study Completion: December 1, 2023
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

FR (1)