Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer (IDEA)
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| ClinicalTrials.gov Identifier: NCT00958737 |
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Recruitment Status :
Active, not recruiting
First Posted : August 13, 2009
Last Update Posted : September 29, 2023
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Colorectal Cancer | Drug: FOLFOX regimen Drug: CAPOX | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 2000 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Actual Study Start Date : | May 12, 2009 |
| Actual Primary Completion Date : | January 2020 |
| Estimated Study Completion Date : | December 2023 |
| Arm | Intervention/treatment |
|---|---|
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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 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
6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6))
Other Name: folinic acid, infusional fluorouracil, and oxaliplatin Drug: CAPOX 4 or 8 cycles
Other Name: capecitabine plus oxaliplatin; XELOX |
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Experimental: Arm II
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).
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Drug: FOLFOX regimen
6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6))
Other Name: folinic acid, infusional fluorouracil, and oxaliplatin Drug: CAPOX 4 or 8 cycles
Other Name: capecitabine plus oxaliplatin; XELOX |
- Disease-free survival (DFS) [ Time Frame: 3 years after randomisation ]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.
- Overall survival (OS) [ Time Frame: Death from randomization; up to 7 years after randomization ]The time from the date of randomization to the date of death from any cause
- Safety profile [ Time Frame: Assessed up to 6 months after randomisation ]All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
- Treatment compliance [ Time Frame: Until 3 months or 6 months (according randomization arm) ]duration, dose intensity, and dose in mg/m2
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958737
| France | |
| GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie | |
| Paris, France, 75011 | |
| Principal Investigator: | Thierry Andre, MD | GERCOR - Multidisciplinary Oncology Cooperative Group |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GERCOR - Multidisciplinary Oncology Cooperative Group |
| ClinicalTrials.gov Identifier: | NCT00958737 |
| Other Study ID Numbers: |
IDEA-C09-1 2009-010384-16 ( EudraCT Number ) EU-20957 ( Other Identifier: EU Clinical Trials Register ) |
| First Posted: | August 13, 2009 Key Record Dates |
| Last Update Posted: | September 29, 2023 |
| Last Verified: | September 2023 |
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stage III colon cancer adenocarcinoma of the colon |
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Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Capecitabine Fluorouracil Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |