Cancer of the Pancreatic Head
Conditions
Brief summary
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
Detailed description
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head. Two cycles of chemotherapy are given on day 1 and 15 each. After restaging excludes disease progression, a standard Whipple procedure is performed. Staging and restaging procedures include abdominal CT, diagnostic laparoscopy, PET/CT, tumor markers (CEA, CA 19-9) and assessment of the quality of life by the QLQ-30. * Trial with medicinal product
Interventions
DRUGGemcitabine / Cisplatin
Sponsors
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Age \> 18 years * Histologically or cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head * WHO-performance status 0-2 * Written informed consent * Discussion in an intrdisciplinary conference
Exclusion criteria
- Insufficient renal function (calculated creatinin clearance \< 60ml(min) * Insufficient hematologic function (neutrophil count \<1'000/ul, platelets \< 100'000/ul) * Uncorrectable coagulopathy * Severe cholestasis (bilirubin \>100mmol/l) * Distant metastases in liver, lungs or other organs * Peritoneal carcinomatosis * Unresectable tumor (s. 4.2.) * Contraindication for Whipple procedure * Uncontrolled infection * Neurotphil count \> °2 * Estimated life experience \< 6 months * HIV Infection * Severe medical or psychatric comorbidities which interefere with the participation in this trial or the informed consent * Female patients in child-bearing age without adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resectability rate > 70% after restaging | 2007 |
Countries
Switzerland
Outcome results
None listed