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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00628368
First received: March 1, 2008
Last updated: December 13, 2009
Last verified: July 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628368

Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle Recruiting
Montpellier, France, 34298
Contact: Marc Ychou, MD, PhD     33-4-6761-3066     mychou@valdorel.fnclcc.fr    
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
Investigators
Study Chair: Marc Ychou, MD, PhD Centre Val d'Aurelle - Paul Lamarque
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov 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:
Rectal Neoplasms
Colorectal Neoplasms
Esophageal Diseases
Esophageal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013