A Phase II Multicentre Study of perioperative Chemotherapy for resectable Adenocarcinoma of the Gastroesophageal Junction and of the Stomach

• Conditions: Resectable Adenokarcinoma of the Gastroesophageal Junction and of the Stomach; MedDRA version: 13.1Level: LLTClassification code 10017768Term: Gastric cancer stage IV without metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: PTClassification code 10017764Term: Gastric cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: PTClassification code 10062878Term: Gastrooesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 13.1Level: PTClassification code 10017765Term: Gastric cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2008-007546-56-DE
• Lead Sponsor: Klinikum der Universität München, Campus Großhadern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-21
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• By means of push-endoscopy (PE) histologically confirmed adenocarcinoma of the gastroesophageal junction (GEJ I-III) and the stomach (every T, N + T3/T4, Nx, M0)
• Signed written consent of the patient
• Age = 18
• Expectedness that surgery may be performed
• ECOG-Performance-Status = 2
• Laparoscopic exclusion of peritoneal carcinoma
• Adequate haematological, renal, cardiac and hepatic function: leukocytes = 3.0 * 109/l; neutrophiles = 1.5 * 109/l; thrombocytes = 100* 109/l; haemoglobin = 9.7 g/dl; serum creatinine 1.25 * upper limit of the normal range (ULNR) or creatinine clearance > 60 ml/min; serum bilirubin = 1.25 * ULNR; ALAT and ASAT = 1. 5 * ULNR
• Effective contraceptive measures for men and women

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pre-existing chemotherapy or radiotherapy for the gastroesophagal junction or the adenocarcinoma
• Non-histologically confirmed primary tumor
• Distant metastasis
• Known hypersensitivity against 5-Flourouracil, Leucovorin, Oxaliplatin or Docetaxel
• Known dihydropyrimdine dehydrogenase (DPD) deficiency
• Peripheral polyneuropathy = grade II (NCI-CTCAE, version 3.0)
• Myocardial infarction in the last 3 months, heart insufficiency grade II-IV (NYHA)
• Severe concomitant diseases or acute infections
• Known drug usage or medication abuse
• Pregnant or lactant women
• Insufficient contraception
• A simultaneous or within a time period of 30 days, participation in studies with one or multiple number of drugs under investigation
• Second neoplasia = 5 years prior study entry (exception: carcinoma in situ of the cervix uteri and an adequately treated basal cell carcinoma)
• Missing or limited contractual capability

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Collection of the R0 resection rate;Secondary Objective: • Collection of the pathologically confirmed complete remission rate <br>• Histological remission-grade in the resection-specimens according to Becker – Criteria (Becker 2003)<br>• Collection of safety and tolerance (NCI-CTCAE, version 3.0)<br>• Surgical and post surgical complications<br>• Progression-free survival (PFS)<br>• Evaluation of prognostic and predictive factors<br>;Primary end point(s): Surgery to remove the tumor after 6 cycles of treatment according to the protocol.