Metabolic Response Evaluation for an Individualization of Neoadjuvant Chemo- and Radiotherapy in Esophageal Adenocarcinoma - MUNICON-2

Conditions: This study will test an optimized therapy for patients with chemotherapy-resistent locally advanced adenocarcinomas at the gastro-esophageal junction.According to the protocol, patients should receive a neoadjuvant radiochemotherapy if the tumor is metabolically not responding to chemotherapy.
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2005-004123-19-DE

Lead Sponsor: Klinikum rechts der Isar der Technischen Universitaet Muenchen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- histologically verified adenocarcinoma at the gastro-esophageal junction
- potentially R0 resectable. Primary tumor category cT3 and cT4
- medically operable patient: risk-score <22 (Bartels)
- intensive FDG-tracerenhancement of the tumor (for follow-up)
- performance-status 0-1 (ECOG); i.e. Karnofsky-index >/= 80%
- age: 18-75 years
- creatinin-clearance >30 ml/min.
- Bilirubin <1,5 mg/dl
- negative pregnancy test (women)
- signed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- remote metastasis (M1b)
- tumor infiltration into the tracheo-bronchial system
- previous chemotherapy and/or radiotherapy of the chest
- uncontrolled infectious disease
- polyneuropathy >I°
- heart failure (> NYHA I)
- pre-operativ risk-score >22 (Bartels)
- uncontrolled diabetes mellitus
- pregnancy or breast-feeding woman

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To optimize the metabolic response rate by using neoadjuvant radiochemotherapy in chemotherapy-resistent adenocarcinomas of the gastro-esophageal junction. Hypothesis: response rate >=30%;Secondary Objective: To optimize the histologic regression by using neoadjuvant radiochemotherapy in chemotherapy-resistent adenocarcinomas of the gastro-esophageal junction. ;Primary end point(s): Metabolic response rate of radiochemotherapy in chemoresistent adenocarcinomas at the esophago-gastric junction. Hypothesis > 30%

Secondary Outcome Measures