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

This study has been terminated.
(Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.)
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00855634
First received: March 3, 2009
Last updated: September 5, 2012
Last verified: July 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms, Second Primary
Pancreatic Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pancreatic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014