Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

Recruiting

• Conditions: Metastases; Neuroendocrine Tumors; Surgery
• Interventions: Other: system treatment; Procedure: system treatment and surgery

• Registration Number: NCT04066322
• Lead Sponsor: Fudan University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study Start: 2019-08-25
• Study First Posted: 2019-08-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-22
• Last Update Posted: 2019-09-24
• Primary Completion: 2024-07-25
• Study Completion: 2025-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
system treatment	system treatment	Patients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy.
system treatment and Surgery	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.

Primary Outcome Measures

Name	Time	Method
progression-free survival	5 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China