Intensified Chemotherapy in CRC After Resection of Liver Metastases

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.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00208260

Enrollment

124

Registered

2005-09-21

Start date

2004-04-01

Completion date

2007-08-01

Last updated

2026-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy, Colorectal Cancer, Liver Metastases

Brief summary

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

Interventions

DRUGFOLFIRI

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

DRUGFOLFOX-4

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

DRUGFOLFIRI-HD

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

DRUGFOLFOX-7

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

DRUGFOLFIRINOX

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Response	end of chemotherapy

Secondary

Measure	Time frame
Safety	during study treatment
Survival	2 years
Secondary resection	surgery after chemotherapy

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarc YCHOU, MD, PhD

CRLC Val d'Aurelle

STUDY_CHAIRMichel RIVOIRE, MD

CRLC Leon Berard - Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026