Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment (RMPanNET)

Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Neuroendocrine Tumors; Metastases
• Intervention / Treatment: Other: system treatment; Procedure: system treatment and surgery

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• 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

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival		5 years
Number of Postoperative morbidity	Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation	Up to 90 days after operation
number of Postoperative mortality		Up to 90 days after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Patients die from any cause during 90 days after operation		5 years
progression-free survival in subgroup analysis	liver metastasis type, grade, extrahepatic metastasis	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2019
• Primary Completion (Anticipated): July 25, 2024
• Study Completion (Anticipated): July 25, 2025

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: CSPAC-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No