Resectable Adenokarcinoma of the Gastroesophageal Junction and of the Stomach MedDRA version: 13.1 Level: LLT Classification code 10017768 Term: Gastric cancer stage IV without metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1 Level: PT Classification code 10017764 Term: Gastric cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 13.1
Conditions
Interventions
Trade Name: Taxotere 20 mg
Product Name: Docetaxel
Product Code: Docetaxel
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Collection of the R0 resection rate;Secondary Objective: • Collection of the pathologically confirmed complete remission rate • Histological remission-grade in the resection-specimens according to Becker – Criteria (Becker 2003) • Collection of safety and tolerance (NCI-CTCAE, version 3.0) • Surgical and post surgical complications • Progression-free survival (PFS) • Evaluation of prognostic and predictive factors ;Primary end point(s): Surgery to remove the tumor after 6 cycles of treatment according to the protocol. | — |
Countries
Germany
Outcome results
None listed