Prospective Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of ERCC1 in Response to Treatment With Neoadjuvant Radiochemotherapy in Patients With Esophageal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Esophageal Cancer
- Sponsor
- Elfriede Bollschweiler
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- histopathologic response to chemoradiation
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: The prognosis of patients with advanced esophageal cancer may be improved by preoperative chemoradiation. But only those patients have a benefit from this additional therapy, whose tumor shows a response after chemoradiation. Molecular markers may help to identify before starting the therapy those patients who response.
PURPOSE: This is the first prospective, clinical trial to study the impact of ERCC1 to predict histopathological response to neoadjuvant radiochemotherapy (RTx/CTx) in patients with cancer of the esophagus.
Investigators
Elfriede Bollschweiler
Professor of Surgical Research
University of Cologne
Eligibility Criteria
Inclusion Criteria
- •informed consent
- •newly diagnosed adenocarcinoma or squamous cell carcinoma of the esophagus or cardia
Exclusion Criteria
- •missing informed consent
- •prior radiation or chemotherapy
- •second malignancy
Outcomes
Primary Outcomes
histopathologic response to chemoradiation
Time Frame: 1 month postoperative
Patients with cT3 esophageal cancer received RTx/CTx according a standardized protocol. 6 weeks after this neoadjuvant therapy a tranthoracic esophagectomy with two-field lymphadenectomy will be performed. The histopathologic response is measured using the surgical specimen.
Secondary Outcomes
- prognosis(2 years after surgical resection)