Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum
Overview
- Phase
- Not Applicable
- Intervention
- Gene expression analysis
- Conditions
- Colorectal Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Determination of predictive factors in the EGFR signaling pathway in response to treatment
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
RATIONALE: Studying samples of tumor tissue and blood 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 predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.
Detailed Description
OBJECTIVES: Primary * Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR. Secondary * Establish a tissue bank to store information about the response to treatment and survival. OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways. After surgery, patients are followed every 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum
- •Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy
- •PATIENT CHARACTERISTICS:
- •Not pregnant or nursing
- •No blood disorder
- •Not deprived of freedom or protected by law
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental: Rectal and oesophagus cancer
Additionnal samples from routine care (tumor tissue and healthy tissue and one blood tube) and standardized clinical data will be entered into a database.
Intervention: Gene expression analysis
Outcomes
Primary Outcomes
Determination of predictive factors in the EGFR signaling pathway in response to treatment
Time Frame: End of study : approximately 4 years