patients with adenocarcinoma of the pancreas MedDRA version: 12.1 Level: LLT Classification code 10052747 Term: Adenocarcinoma pancreas
Conditions
Interventions
Trade Name: GEMZAR
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: GEMCITABINE
CAS Number: 95058-81-4
Concentration unit: g gram(s)
Concentration type: equal
Concentration n
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: patients with adenocarcinoma of the pancreas UICC stadium I-III without metastases Karnofsky-Index of 80 and more 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: carcinoma of the ampulla vateri carcinoma located in the tail or engaging more than 50 % of the corpus carcinoma of the pancreas other than adenocarcinoma previous tumor specific treatment relapse of a tumor metastases carcinosis of the peritoneum cirrhosis of the liver Serumcreatinine more than 1,5 mg/dl, Creatinine-Clearance less than 70 ml/min severe cardiopulmonary diseases HIV Infection Necessarity of immunosuppression serious wounds, ulcera or fractures that do not heal myelosuppression before the beginning of the therapy with Oxaliplatine, proven by neutrocytes less than 2 x 10E9/l and/or thrombocytes less than 100 x 10E9/l peripheric sensoric neuropathia with functionary loss before the beginning of the therapy with Oxaliplatine patients with ferromagnetic implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to determine the responserate of radio-/chemotherapy by means of standard uptake value determined in a PET-CT;Secondary Objective: 1 year and 3 years survival rate free of illness Common Toxicity Criteria R0-Resection rate Incidence of perioperative morbidity and mortality Determination of the responserate by means of ADC-perf and ADC-diff in a MRT Determination of the responsrate by RECIST criteria Determination of overall survival time Quality of life before, during and after therapy;Primary end point(s): Standard Uptake Value (PET-CT) | — |
Countries
Germany
Outcome results
None listed