Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München - Full Text View

Purpose

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 infiltration.

Condition	Intervention
Pancreatic Cancer	Procedure: Resection of metastases Procedure: Resection of infiltrated veins

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Extended Versus Standard Resection in Two Cohorts of Patients With Adenocarcinoma of the Pancreas: Minimal Metastatic Disease or Venous Infiltration - a Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival [ Time Frame: Additional 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	355
Study Start Date:	August 2009
Study Completion Date:	March 2012

Arms	Assigned Interventions
Active Comparator: 1 COHORT 1 (minimal metastatic disease): Arm 1 (intervention): resection of the primary tumor, followed by resection of the liver metastasis/metastases Arm 2 (control): exploration and/or gastroenterostomy and/or hepaticojejunostomy/choledochojejunostomy	Procedure: Resection of metastases resection of the primary tumor, followed by resection of the liver metastasis/metastases
Active Comparator: 2 COHORT 2 (venous infiltration): Arm 1 (intervention): resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) Arm 2 (control): resection of the primary tumor with dissection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) plus tumor masses adjacent to these veins; no venous resection	Procedure: Resection of infiltrated veins resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic

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. Patients will be randomized intraoperatively after fulfilling all inclusion criteria (in particular: suspicion of cancer of the pancreas and an intraoperative histologically proven diagnosis of pancreatic adenocarcinoma; intraoperative assessment of tumor as potentially locally respectable). If no metastases and no infiltration of the portal vein are detected during the operation, the standard resection will be performed (for tumors of the pancreatic head: (pylorus-preserving) pancreaticoduodenectomy; for tumors of the pancreatic body/tail: distal (left) pancreatic resections; for tumors of the head and body/tail: total pancreatectomy). In the case of tumor infiltration of the pyloric region or the distal stomach, a classical pancreaticoduodenectomy will be performed.

If the patient has pancreatic cancer with minimal metastatic disease (COHORT 1) and fulfills all inclusion criteria, she/he will be randomized into one of the following arms:

Arm 1 (intervention): resection of the primary tumor, followed by resection of the liver metastasis/metastases
Arm 2 (control): exploration and/or gastroenterostomy and/or hepaticojejunostomy/choledochojejunostomy

If there are no liver metastases, following mobilization (and potentially also the dissection of the pancreas at the pancreatic head), the extension of the tumor towards the superior mesenteric/splenic/portal vein is examined. If there is venous infiltration (COHORT 2) and the patient fulfills the inclusion criteria, she/he will be randomized into one of the following arms:

Arm 1 (intervention): resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV)
Arm 2 (control): resection of the primary tumor with dissection of the portal vein (and/or superior mesenteric vein/splenic vein (SMV/SV) plus tumor masses adjacent to these veins; no venous resection The aim of this study is to demonstrate that an extension of the resectability criteria in patients with pancreatic cancer and 1) minimal metastatic disease OR 2) venous infiltration improves overall survival. A secondary aim of the study is to prove that resection in these patient cohorts improves quality of life.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855634

Locations

Germany
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München Ismaningerstrasse 22 81675 München, Germany
München, Germany

Sponsors and Collaborators

Technische Universität München

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00855634 History of Changes
Other Study ID Numbers:	TUM-Chir-001/2009
Study First Received:	March 3, 2009
Last Updated:	September 5, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Technische Universität München:

Pancreatic cancer
metastasis
venous infiltration
Pancreatic cancer with minimal metastatic disease or venous infiltration

Additional relevant MeSH terms:

Neoplasm Metastasis
Pancreatic Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms

Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013

Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München (PaMeViTUM)