Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00628368
• Other study ID #: CDR0000574175
• Secondary ID: CLCC-EGFR-BIOINC
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2008
• Last updated: December 13, 2009
• Start date: November 2005

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Genetic:
• gene expression analysis

• mutation analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

Procedure:
• biopsy

• endoscopic biopsy

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of predictive factors in the EGFR signaling pathway in response to treatment
Secondary	Establishment of a tissue bank