NCT00855634

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 infiltration.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable pancreatic-cancer

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 6, 2012

Status Verified

July 1, 2009

First QC Date

March 3, 2009

Last Update Submit

September 5, 2012

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancermetastasisvenous infiltrationPancreatic cancer with minimal metastatic disease or venous infiltration

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    3 years

Secondary Outcomes (1)

  • Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival

    Additional 2 years

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

Resection of metastasesPROCEDURE

resection of the primary tumor, followed by resection of the liver metastasis/metastases

1
Resection of infiltrated veinsPROCEDURE

resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • +4 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

München, Germany

Location

Related Publications (1)

  • Argentiero A, Calabrese A, Sciacovelli AM, Delcuratolo S, Solimando AG, Brunetti O. Complete Response of Synchronous Liver Metastasis in a Pancreatic Ductal Adenocarcinoma, When Surgery Could Represent a Therapeutic Option. Can J Gastroenterol Hepatol. 2020 Oct 9;2020:8679751. doi: 10.1155/2020/8679751. eCollection 2020.

    PMID: 33102398DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

August 1, 2009

Study Completion

March 1, 2012

Last Updated

September 6, 2012

Record last verified: 2009-07

Locations

DE(1)