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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Esophageal Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Outcome Measure:

Role of predictive factors in the EGFR signaling pathway in response to treatment

Principal Investigator

Marc Ychou, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Val d'Aurelle - Paul Lamarque

Authority:

Unspecified

Study ID:

CDR0000574175

NCT ID:

NCT00628368

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Esophageal Cancer
  • 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
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms

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