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

Pancreatic Cancer Clinical Trial

— PaMeViTUM  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855634
• Other study ID #: TUM-Chir-001/2009
• Status: Terminated
• Phase: N/A
• First received: March 3, 2009
• Last updated: September 5, 2012
• Start date: August 2009
• Est. completion date: March 2012

Study information

• Verified date: July 2009
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 infiltration.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 355
• Est. completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Resection of metastases
resection of the primary tumor, followed by resection of the liver metastasis/metastases
• Resection of infiltrated veins
resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		3 years	Yes
Secondary	Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival		Additional 2 years	Yes