Back to resultsBiological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
Primary Purpose
Colorectal Cancer, Esophageal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gene expression analysis
mutation analysis
polymorphism analysis
laboratory biomarker analysis
biopsy
endoscopic biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Centre Regional de Lutte Contre le Cancer - Centre Val d'AurelleRecruiting
Outcomes
Primary Outcome Measures
Role of predictive factors in the EGFR signaling pathway in response to treatment
Secondary Outcome Measures
Establishment of a tissue bank
Full Information
NCT ID
NCT00628368
First Posted
March 1, 2008
Last Updated
December 13, 2009
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT00628368
Brief Title
Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Esophageal Cancer
Keywords
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
mutation analysis
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
endoscopic biopsy
Primary Outcome Measure Information:
Title
Role of predictive factors in the EGFR signaling pathway in response to treatment
Secondary Outcome Measure Information:
Title
Establishment of a tissue bank
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Ychou, MD, PhD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Ychou, MD, PhD
Phone
33-4-6761-3066
Email
mychou@valdorel.fnclcc.fr
12. IPD Sharing Statement
Learn more about this trial
Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
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