Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
18 Years
N/A
Both
Cancer of the Pancreatic Head
Trial Information
Neoadjuvant Chemotherapy for Resectable Cancer of the Pancreatic Head
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Resectability rate > 70% after restaging
Outcome Time Frame:
2007
Principal Investigator
01 Studienregister MasterAdmins
Investigator Role:
Study Director
Investigator Affiliation:
UniversitaetsSpital Zuerich
Authority:
Switzerland: Swissmedic
Study ID:
21-2001
NCT ID:
NCT00490360
Start Date:
October 2001
Completion Date:
May 2007
Related Keywords:
- Cancer of the Pancreatic Head
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