Status:
TERMINATED
Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München
Lead Sponsor:
Technical University of Munich
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
PaMeViTUM is a mono-centric prospective randomized controlled trial that compares different operating procedures in patients with pancreatic cancer and minimal metastatic disease or venous infiltratio...
Detailed Description
PaMeViTUM is a mono-centric prospective randomized controlled trial comparing different operating procedures in patients with pancreatic cancer and minimal metastatic disease or venous infiltration. P...
Eligibility Criteria
Inclusion
- suspicion of cancer of the pancreas and an intraoperative histologically proven diagnosis of pancreatic adenocarcinoma.
- intraoperative assessment of tumor as potentially locally resectable
- COHORT 1: Minimal metastatic disease
- COHORT 2: Venous infiltration
- ability to sign the informed consent.
- Karnofsky performance status \> 70.
- Life-expectancy of more than 3 months.
- able to attend follow-up.
- no previous or concurrent malignancy diagnoses, except non-melanoma skin cancer and in situ carcinoma of the cervix.
- no serious medical, psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up.
- patients older than 18 years.
- no pregnant or lactating women.
- preoperative evaluation by thin-sliced CT scans with:
- No evidence of substantial extra-pancreatic disease, i.e. no evidence of malignant ascites, extended liver metastasis (\>5 metastatic lesions), spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.
- No evidence of extension of the tumor into the celiac axis or superior mesenteric artery (T4 disease).
- intraoperative findings with:
- tumor assessed as potentially locally resectable.
- no signs of peritoneal metastasis or tumor manifestations outside of the pancreas and the liver.
- frozen section: adenocarcinoma
Exclusion
- extrapancreatic disease (except minimal metastatic disease of the liver, see above)
- concomitant venous infiltration and minimal metastatic disease
- extension of the tumor into the celiac axis or superior mesenteric artery
- life expectancy of less than 3 months
- previous or concurrent malignancy diagnosis, except non-melanoma skin cancer and in situ carcinoma of the cervix
- conditions potentially hampering compliance (also inclusion criteria)
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2012
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00855634
Start Date
August 1 2009
End Date
March 1 2012
Last Update
September 6 2012
Active Locations (1)
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1
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München Ismaningerstrasse 22 81675 München, Germany
München, Germany