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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


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

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

histopathologic response to chemoradiation

Outcome Description:

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.

Outcome Time Frame:

1 month postoperative

Safety Issue:

No

Principal Investigator

Arnulf H. Hölscher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of General, Visceral and Cancer Surgery, University of Cologne

Authority:

Germany: Ethics Commission

Study ID:

UK-09-118

NCT ID:

NCT00953511

Start Date:

August 2009

Completion Date:

March 2013

Related Keywords:

  • Esophageal Cancer
  • esophagus
  • chemoradiation
  • excision repair cross-complementing gene
  • polymorphism
  • response prediction
  • Esophageal Diseases
  • Esophageal Neoplasms

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