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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Esophageal Cancer
• Intervention / Treatment: Genetic: Gene expression analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Rectal and oesophagus cancer; Additionnal samples from routine care (tumor tissue and healthy tissue and one blood tube) and standardized clinical data will be entered into a database.	Genetic: Gene 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Establishment of a tissue bank

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Study Chair: Marc Ychou, MD, PhD, Institut du Cancer de Montpellier - Val d'aurelle

Publications and helpful links

General Publications

• Arsic N, Ho-Pun-Cheung A, Lopez-Crapez E, Assenat E, Jarlier M, Anguille C, Colard M, Pezet M, Roux P, Gadea G. The p53 isoform delta133p53ss regulates cancer cell apoptosis in a RhoB-dependent manner. PLoS One. 2017 Feb 17;12(2):e0172125. doi: 10.1371/journal.pone.0172125. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2005
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 30, 2009

Study Registration Dates

• First Submitted: March 1, 2008
• First Submitted That Met QC Criteria: March 1, 2008
• First Posted (Estimated): March 5, 2008

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: adenocarcinoma of the rectum; stage IV rectal cancer; recurrent rectal cancer; stage II esophageal cancer; stage III esophageal cancer; squamous cell carcinoma of the esophagus; adenocarcinoma of the esophagus; recurrent esophageal cancer; stage II rectal cancer; stage III rectal cancer; stage IV esophageal cancer; stage I rectal cancer; stage I esophageal cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Colonic Diseases; Esophageal Diseases; Carcinoma; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Rectal Neoplasms; Colorectal Neoplasms; Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Investigative Techniques; Genetic Techniques; Gene Expression Profiling
• Other Study ID Numbers: CDR0000574175; CLCC-EGFR-BIO; INCA-RECF0366

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No