Study of Tumor Tissue Testing in Selecting Treatment for Patients With Metastatic or Locally Advanced Colorectal Cancer

Sponsor
Medical Research Council
Study ID
NCT00975897
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
  • cetuximab — BIOLOGICAL
  • fluorouracil — DRUG
  • irinotecan hydrochloride — DRUG
  • leucovorin calcium — DRUG
  • oxaliplatin — DRUG
  • RNA analysis — GENETIC
  • cytogenetic analysis — GENETIC
  • fluorescence in situ hybridization — GENETIC
  • gene expression analysis — GENETIC
  • mutation analysis — GENETIC
  • protein expression analysis — GENETIC
  • diagnostic laboratory biomarker analysis — OTHER
  • immunohistochemistry staining method — OTHER
  • questionnaire administration — OTHER
  • cognitive assessment — PROCEDURE

Study Details

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment. PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.

Key Dates

Start date
Jul 31, 2009
Status verified
Aug 2011
Primary completion
Aug 31, 2010
Completion
Dec 31, 2012

Study Design

Enrollment
3,240 participants (estimated)
Allocation
RANDOMIZED
Primary purpose
DIAGNOSTIC

Primary Outcome Measure

Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration

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