Colorectal CancerPhase 3IDEANCT00958737
Combination Chemotherapy for 3 Months or 6 Months in Treating Patients With Stage III Colon Cancer
A Phase 3 study testing FOLFOX regimen and CAPOX in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- FOLFOX regimen and CAPOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 12 May 2009to Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie
Paris, 75011
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- FOLFOX regimen, CAPOX
- Keywords
- stage III colon cancer, adenocarcinoma of the colon
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFOX regimenDrug
Also called folinic acid, infusional fluorouracil, and oxaliplatin
6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6))
CAPOXDrug
Also called capecitabine plus oxaliplatin; XELOX
4 or 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Drug: FOLFOX regimen; Drug: CAPOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years after randomisation
Secondary outcomes (3)
Overall survival (OS)
The time from the date of randomization to the date of death from any cause
Measured: Death from randomization; up to 7 years after randomization
Safety profile
All grade and severe toxicities, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: Assessed up to 6 months after randomisation
Treatment compliance
duration, dose intensity, and dose in mg/m2
Measured: Until 3 months or 6 months (according randomization arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study start12 May 2009
- Primary completionJan 2020
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Andre, MD, Principal investigator, GERCOR - Multidisciplinary Oncology Cooperative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958737
- Sponsor's protocol ID
- IDEA-C09-1
- Other IDs
- 2009-010384-16, EU-20957, 2009
- Acronym
- IDEA
- Status last verified
- Sep 2023
- First submitted
- 12 Aug 2009
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29620995Taieb 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.
PubMed 39903903Gallois 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.
PubMed 39889251Gallois 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.
PubMed 36306483Delattre 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.
PubMed 32167864
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00958737
- Acronym / sponsor ID
- IDEA / IDEA-C09-1
- Conditions
- Colorectal Cancer
- Keywords
- stage III colon cancer, adenocarcinoma of the colon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- GERCOR - Multidisciplinary Oncology Cooperative GroupUniversity, hospital or other
- Study start
- 12 May 2009 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: FOLFOX regimen, Drug: CAPOXPatients 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) |
| Arm II | Experimental | Drug: FOLFOX regimen, Drug: CAPOXPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FOLFOX regimenAlso: folinic acid, infusional fluorouracil, and oxaliplatin6 or 12 treatments of FOLFOX (FOLFOX4 or modified FOLFOX6 (mFOLFOX6)) | Drug | Arm I, Arm II |
| CAPOXAlso: capecitabine plus oxaliplatin; XELOX4 or 8 cycles | Drug | Arm I, Arm II |
Primary outcome
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.
3 secondary outcomes
Overall survival (OS)
Time frame: Death from randomization; up to 7 years after randomization
Safety profile
Time frame: Assessed up to 6 months after randomisation
Treatment compliance
Time frame: Until 3 months or 6 months (according randomization arm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Results publication: PubMed 29620995Andre 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.
- Derived from this study: PubMed 39903903Taieb 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.
- Derived from this study: PubMed 39889251Gallois 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.
- Derived from this study: PubMed 36306483Gallois 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.
- Derived from this study: PubMed 32167864Delattre 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.
- IDEA France phase III trialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Andre, MD principal investigator
GERCOR - Multidisciplinary Oncology Cooperative Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOLFOX regimen and CAPOX in people with Colorectal Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: 3 years after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00958737, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.