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RMPanNET: Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04066322
Collaborator
(none)
180
Enrollment
1
Location
71
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: system treatment and surgery
  • Other: system treatment

Detailed Description

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
Actual Study Start Date :
Aug 25, 2019
Anticipated Primary Completion Date :
Jul 25, 2024
Anticipated Study Completion Date :
Jul 25, 2025

Arms and Interventions

Arm Intervention/Treatment
system treatment

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

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.
Other Names:
  • resection of primary and metastatic tumors

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [5 years]

    Secondary Outcome Measures

    1. overall survival [5 years]

    2. Number of Postoperative morbidity [Up to 90 days after operation]

      Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation

    3. number of Postoperative mortality [Up to 90 days after operation]

    Other Outcome Measures

    1. number of Patients die from any cause during 90 days after operation [5 years]

    2. progression-free survival in subgroup analysis [5 years]

      liver metastasis type, grade, extrahepatic metastasis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xian-Jun Yu, Principal Investigator, Fudan University
    ClinicalTrials.gov Identifier:
    NCT04066322
    Other Study ID Numbers:
    • CSPAC-26
    First Posted:
    Aug 26, 2019
    Last Update Posted:
    Sep 24, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroendocrine Tumors

    Study Results

    No Results Posted as of Sep 24, 2019