Pancreatic CancerPaMeViTUMNCT00855634
Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München
A study testing Resection of metastases and Resection of infiltrated veins in people with Pancreatic Cancer, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Resection of metastases and Resection of infiltrated veins
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Surgery and Institute of Statistics Klinikum rechts der Isar der Technischen Universität München Ismaningerstrasse 22 81675 München, Germany
München
About this study
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
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Resection of metastases, Resection of infiltrated veins
- Keywords
- Pancreatic cancer, metastasis, venous infiltration, Pancreatic cancer with minimal metastatic disease or venous infiltration
- Medical subject headings
- Pancreatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resection of metastasesProcedure or surgery
resection of the primary tumor, followed by resection of the liver metastasis/metastases
Resection of infiltrated veinsProcedure or surgery
resection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Resection of infiltrated veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Secondary outcomes (1)
Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival
Measured: Additional 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startAug 2009
- Study completionMar 2012
Why it stopped: Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855634
- Sponsor's protocol ID
- TUM-Chir-001/2009
- Acronym
- PaMeViTUM
- Status last verified
- Jul 2009
- First submitted
- 3 Mar 2009
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33102398
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00855634
- Acronym / sponsor ID
- PaMeViTUM / TUM-Chir-001/2009
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic cancer, metastasis, venous infiltration, Pancreatic cancer with minimal metastatic disease or venous infiltration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2009
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Resection of metastasesCOHORT 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 |
| 2 | Active comparator | Procedure: Resection of infiltrated veinsCOHORT 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resection of metastasesresection of the primary tumor, followed by resection of the liver metastasis/metastases | Procedure or surgery | 1 |
| Resection of infiltrated veinsresection of the primary tumor with resection of the portal vein (and/or superior mesenteric vein/splenic | Procedure or surgery | 2 |
Primary outcome
Overall survival
Time frame: 3 years
1 secondary outcome
Quality of life Perioperative morbidity and mortality 1-year survival and 2-year survival
Time frame: Additional 2 years
Results and safety
The study was stopped early (reason given: Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
- Derived from this study: PubMed 33102398Argentiero 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resection of metastases and Resection of infiltrated veins in people with Pancreatic Cancer, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Protocol planned interim analysis after two years showed very low recruitment in cohort 1 and low recruitment in cohort 2.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.