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A Multicentre Randomized Phase II Study to Assess the Safety and Resectablity in Patients With Primarily Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving Treatment With 5-FU, Leucovorin, Oxaliplatin and Bevacizumab With or Without Irinotecan as 1st Line Treatment.


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Multicentre Randomized Phase II Study to Assess the Safety and Resectablity in Patients With Primarily Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving Treatment With 5-FU, Leucovorin, Oxaliplatin and Bevacizumab With or Without Irinotecan as 1st Line Treatment.


Inclusion Criteria:



- adult patients, >=18 and <=70 years of age;

- unresectable liver metastasis secondary to cancer of colon or rectum;

- scheduled for standard first line chemotherapy;

- ECOG performance score of 0 or 1;

- condition feasible for major abdominal surgery after first line treatment.

Exclusion Criteria:

- diagnosis of metastatic disease >3 months prior to study entry;

- evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of
celiac lymph nodes;

- prior systemic or local treatment of metastatic disease;

- prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to
study entry;

- history or evidence of CNS disease unrelated to cancer.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Resection rate of liver metastases after neoadjuvant treatment

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Austria: Ethikkommission

Study ID:

MO18725

NCT ID:

NCT00778102

Start Date:

October 2008

Completion Date:

August 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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