Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
Status and phase
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Treatments
Details and patient eligibility
About
Neodajuvant chemotherapy with gemcitabine / cisplatin is applied to patients with resectable cancer of pancreatic head.
Full 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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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