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

Summary

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.

Conditions

• Colorectal Cancer

Interventions

BIOLOGICAL

bevacizumab

BIOLOGICAL

cetuximab

DRUG

fluorouracil

DRUG

irinotecan hydrochloride

DRUG

leucovorin calcium

DRUG

oxaliplatin

GENETIC

RNA analysis

GENETIC

cytogenetic analysis

GENETIC

fluorescence in situ hybridization

GENETIC

gene expression analysis

GENETIC

mutation analysis

GENETIC

protein expression analysis

OTHER

diagnostic laboratory biomarker analysis

OTHER

immunohistochemistry staining method

OTHER

questionnaire administration

PROCEDURE

cognitive assessment

Sponsors & Collaborators

• Medical Research Council

  lead OTHER_GOV

Principal Investigators

• Timothy Maughan, MD · Velindre NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-07-31

Primary Completion

2010-08-31

Completion

2012-12-31

Countries

• United Kingdom

Study Locations