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| Sponsored by: |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00628368 |
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 |
Procedure: biopsy Procedure: endoscopic biopsy Procedure: gene expression analysis Procedure: laboratory biomarker analysis Procedure: mutation analysis Procedure: polymorphism analysis |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized |
| 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 |
| Estimated Enrollment: | 160 |
| Study Start Date: | August 2005 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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 |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and 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 | |
| Study Chair: | Marc Ychou, MD, PhD | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle |
More Information
| Study ID Numbers: | CDR0000574175, CLCC-EGFR-BIO, INCA-RECF0366 |
| Study First Received: | March 1, 2008 |
| Last Updated: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00628368 |
| Health Authority: | Unspecified |
|
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 |
|
Digestive System Neoplasms Esophageal disorder Rectal Neoplasms Gastrointestinal Diseases Squamous cell carcinoma Esophageal Neoplasms Colonic Diseases Intestinal Diseases Rectal Diseases Recurrence Intestinal Neoplasms Rectal neoplasm |
Carcinoma Epidermoid carcinoma Digestive System Diseases Head and Neck Neoplasms Carcinoma, squamous cell Gastrointestinal Neoplasms Esophageal Diseases Carcinoma, Squamous Cell Adenocarcinoma Rectal cancer Esophageal neoplasm Colorectal Neoplasms |
|
Neoplasms Neoplasms by Site |
