Colorectal CancerPhase 2/3NCT00208260
Intensified Chemotherapy in CRC After Resection of Liver Metastases
A Phase 2/3 study testing FOLFIRI, FOLFOX-4 and FOLFIRI-HD in people with Colorectal Cancer and Liver Metastases, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer, Liver Metastases, Chemotherapy
- What is being tested?
- FOLFIRI, FOLFOX-4 and FOLFIRI-HD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2004to Aug 2007
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
- Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
- Not optimally resectable metastases
- Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
- Synchronous and metachronous hepatic metastases
- WHO performance status 0-1
Show all 9Show fewer
- Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
- No prior treatment of the liver metastases, whatever.
- Life expectancy equal or more than 3 months
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
- Conditions
- Colorectal Cancer, Liver Metastases, Chemotherapy
- Being tested
- FOLFIRI, FOLFOX-4, FOLFIRI-HD, FOLFOX-7, FOLFIRINOX
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOLFIRIDrug
FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
FOLFOX-4Drug
FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
FOLFIRI-HDDrug
High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
FOLFOX-7Drug
FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
FOLFIRINOXDrug
FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | FOLFIRI Receives: Drug: FOLFIRI |
| B | Active comparator | FOLFOX-4 Receives: Drug: FOLFOX-4 |
| C | Experimental | FOLFIRI-HD Receives: Drug: FOLFIRI-HD |
| D | Experimental | FOLFOX-7 Receives: Drug: FOLFOX-7 |
| E | Experimental | FOLFIRINOX Receives: Drug: FOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response
Measured: end of chemotherapy
Secondary outcomes (3)
Safety
Measured: during study treatment
Survival
Measured: 2 years
Secondary resection
Measured: surgery after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Marc YCHOU, MD, PhD, Principal investigator, CRLC Val d'AurelleMichel RIVOIRE, MD, Study chair, CRLC Leon Berard - Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208260
- Sponsor's protocol ID
- METHEP/2004/22
- Status last verified
- Feb 2026
- First submitted
- 13 Sep 2005
- Last updated
- 5 Feb 2026
- Results posted
- No
Publications
Ychou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, Letoublon C, Guimbaud R, Francois E, Ducreux M, Desseigne F, Fabre JM, Assenat E. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. The METHEP trial. Ann Surg Oncol. 2013 Dec;20(13):4289-97. doi: 10.1245/s10434-013-3217-x. Epub 2013 Aug 17.
PubMed 23955585
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard Bi-therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.
- ClinicalTrials.gov ID
- NCT00208260
- Acronym / sponsor ID
- METHEP/2004/22
- Conditions
- Colorectal Cancer, Liver Metastases, Chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Collaborators
- Pfizer, Sanofi, Chugai Pharmaceutical
- Study start
- Apr 2004
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Sep 2005 (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.
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: FOLFIRIFOLFIRI |
| B | Active comparator | Drug: FOLFOX-4FOLFOX-4 |
| C | Experimental | Drug: FOLFIRI-HDFOLFIRI-HD |
| D | Experimental | Drug: FOLFOX-7FOLFOX-7 |
| E | Experimental | Drug: FOLFIRINOXFOLFIRINOX |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
- Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
- Not optimally resectable metastases
- Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
- Synchronous and metachronous hepatic metastases
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| FOLFIRIFOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks | Drug | A |
| FOLFOX-4FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks | Drug | B |
| FOLFIRI-HDHigh Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks | Drug | C |
| FOLFOX-7FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks | Drug | D |
| FOLFIRINOXFOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks | Drug | E |
Primary outcome
Response
Time frame: end of chemotherapy
3 secondary outcomes
Safety
Time frame: during study treatment
Survival
Time frame: 2 years
Secondary resection
Time frame: surgery after chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Results publication: PubMed 23955585Ychou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, Letoublon C, Guimbaud R, Francois E, Ducreux M, Desseigne F, Fabre JM, Assenat E. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. The METHEP trial. Ann Surg Oncol. 2013 Dec;20(13):4289-97. doi: 10.1245/s10434-013-3217-x. Epub 2013 Aug 17.
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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.
Marc YCHOU, MD, PhD principal investigator
CRLC Val d'Aurelle
Michel RIVOIRE, MD study chair
CRLC Leon Berard - Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing FOLFIRI, FOLFOX-4 and FOLFIRI-HD in people with Colorectal Cancer and Liver Metastases, run by Institut du Cancer de Montpellier - Val d'Aurelle 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 1 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: finished, as of the sponsor's last update on 5 Feb 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response (time frame: end of chemotherapy). 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 NCT00208260, which also lists 1 linked publication.
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 5 Feb 2026.