Palliative pylorus-preserving pancreatic head resection and postoperative chemotherapy versus primary chemotherapy alone for patients with advanced carcinoma of the pancreatic head

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
INTERVENTION: Group 1: standard pylorus‐preserving pancreatic head resection with regional lymphadenectomy (this is an internationally well accepted surgical procedure) and after completion of wound healing (up to four weeks postoperative) standard chemotherapy with gemcitabine is started (see below). The chemotherapy is the same as in group 2. Group 2: standard gemcitabine chemotherapy alone: 1000 mg/m^2 body surface once per week for four weeks with a one‐week break, i.e., three weeks treatment and one week free. This is an internationally accepted standard for gemcitabine in advanced pancreatic carcinoma treatment. Drugs will be administered on an out patient basis intravenously (i.v.) through a port system. Follow up period is one year. CONDITION: Pancreatic head carcinoma ; Cancer ; Pancreatic head carcinoma PRIMARY OUTCOME: Survival, measured after 3, 6 and 12 months SECONDARY OUTCOME: 1. Quality of life, measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ‐C30) and the EORTC Quality of Life Questionnaire for Pancreatic cancer (QLQ PAN26). This will be measured after 3, 6 and 12 months; 2. Surgical complications, measured after 3, 6 and 12 months; 3. Toxicity of chemotherapy, measured after 3, 6 and 12 months INCLUSION CRITERIA: Medical centres experienced in surgical and medical care of patients with pancreatic head carcinoma.
Epistemonikos ID: 7d13bdbd5df2a8b7d7d92a23a1bb41d986862acd
First added on: Aug 21, 2024