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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.


Phase 2/Phase 3
18 Years
75 Years
Not Enrolling
Both
Colorectal Cancer, Liver Metastases, Chemotherapy

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Trial Information

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.


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:

-

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response

Outcome Time Frame:

end of chemotherapy

Safety Issue:

No

Principal Investigator

Marc YCHOU, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CRLC Val d'Aurelle

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

METHEP/2004/22

NCT ID:

NCT00208260

Start Date:

April 2004

Completion Date:

August 2007

Related Keywords:

  • Colorectal Cancer
  • Liver Metastases
  • Chemotherapy
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

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