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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 1, 2008
Last updated: December 13, 2009
Last verified: July 2009

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.

Condition Intervention
Colorectal Cancer
Esophageal Cancer
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Procedure: biopsy
Procedure: endoscopic biopsy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Role of predictive factors in the EGFR signaling pathway in response to treatment

Secondary Outcome Measures:
  • Establishment of a tissue bank

Estimated Enrollment: 160
Study Start Date: November 2005
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:



  • Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.


  • 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum
  • Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy


  • Not pregnant or nursing
  • No blood disorder
  • Not deprived of freedom or protected by law


  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its identifier: NCT00628368

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD    33-4-6761-3066   
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Study Chair: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information Identifier: NCT00628368     History of Changes
Other Study ID Numbers: CDR0000574175  CLCC-EGFR-BIO  INCA-RECF0366 
Study First Received: March 1, 2008
Last Updated: December 13, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
squamous cell carcinoma of the esophagus
adenocarcinoma of the rectum
recurrent rectal cancer
stage I rectal cancer
stage II rectal cancer
stage III rectal cancer
stage IV rectal cancer
recurrent esophageal cancer
stage I esophageal cancer
stage II esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site processed this record on May 26, 2016