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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00628368

Enrollment

160

Registered

2008-03-05

Start date

2005-11-01

Completion date

2009-09-30

Last updated

2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

GENETICGene expression analysis

Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. One blood tube will be frozen. During a coloscopy or gastroscopy tumor and health tissue samples will be taken for diagnosis and research.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Determination of predictive factors in the EGFR signaling pathway in response to treatment	End of study : approximately 4 years

Countries

France

Contacts

STUDY_CHAIRMarc Ychou, MD, PhD

Institut du Cancer de Montpellier - Val d'Aurelle

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026