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Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment


2019-08-25


2024-07-25


2025-07-25


180

Study Overview

Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.

system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.

  • Neuroendocrine Tumors
  • Metastases
  • Surgery
  • PROCEDURE: system treatment and surgery
  • OTHER: system treatment
  • CSPAC-26

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-08-21  

N/A  

2019-09-22  

2019-08-21  

N/A  

2019-09-24  

2019-08-26  

N/A  

2019-09  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: system treatment

Patients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy.

PROCEDURE: system treatment and surgery

  • to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments.

OTHER: system treatment

  • to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment.
: system treatment and Surgery

Patients receive synchronous resection of primary tumor and metastasis after system treatment. and treatment after surgery is based on the clinical decision.

PROCEDURE: system treatment and surgery

  • to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments.
Primary Outcome MeasuresMeasure DescriptionTime Frame
progression-free survival5 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
overall survival5 years
Number of Postoperative morbidityIncluding pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperationUp to 90 days after operation
number of Postoperative mortalityUp to 90 days after operation

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: xianjun yu, MD

Phone Number: +86 21 64175590

Email: yuxianjun@fudanpci.org

Study Contact Backup

Name: Heli Gao

Phone Number: +86 21 64175590

Email: gaoheli@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Biopsy-proven neuroendocrine tumor 2. primary site in pancreas 3. Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis 4. curative intent of all therapies possible 5. ECOG 0-2
    Exclusion Criteria:
    1. Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor 2. functioning NET or advanced carcinoid heart disease 3. part of hereditary syndrome, such as MEN1, VHL 4. do not willing to receive systemic treatment 5. diagnosed with other cancer within 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available