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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628368
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 5, 2008
Last Update Posted : December 15, 2009
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Esophageal Cancer Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Procedure: biopsy Procedure: endoscopic biopsy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
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
Study Start Date : November 2005
Estimated Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  1. Establishment of a tissue bank

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628368

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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
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Study Chair: Marc Ychou, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
Layout table for additonal information Identifier: NCT00628368    
Other Study ID Numbers: CDR0000574175
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: July 2009
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:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Diseases