NCT00208260

Brief Summary

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

First QC Date

September 13, 2005

Last Update Submit

February 3, 2026

Conditions

Colorectal CancerLiver MetastasesChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Response

    end of chemotherapy

Secondary Outcomes (3)

  • Safety

    during study treatment

  • Survival

    2 years

  • Secondary resection

    surgery after chemotherapy

Study Arms (5)

A

ACTIVE COMPARATOR

FOLFIRI

Drug: FOLFIRI

B

ACTIVE COMPARATOR

FOLFOX-4

Drug: FOLFOX-4

C

EXPERIMENTAL

FOLFIRI-HD

Drug: FOLFIRI-HD

D

EXPERIMENTAL

FOLFOX-7

Drug: FOLFOX-7

E

EXPERIMENTAL

FOLFIRINOX

Drug: FOLFIRINOX

Interventions

FOLFIRIDRUG

FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks

A
FOLFOX-4DRUG

FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks

B
FOLFIRI-HDDRUG

High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks

C
FOLFOX-7DRUG

FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks

D
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

E

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRLC Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

  • 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.

    PMID: 23955585RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

IFL protocolFolfox protocolfolfirinox

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Marc YCHOU, MD, PhD

    CRLC Val d'Aurelle

    PRINCIPAL INVESTIGATOR

  • Michel RIVOIRE, MD

    CRLC Leon Berard - Lyon

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2004

Study Completion

August 1, 2007

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

FR(1)