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

Fudan University

Status: Enrolling

Conditions: Surgery; Metastases; Neuroendocrine Tumors

Treatments: Other: system treatment; Procedure: system treatment and surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04066322

CSPAC-26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

180 participants in 2 patient groups

system treatment

Description:

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

Treatment:

Other: system treatment

system treatment and Surgery

Description:

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

Treatment:

Procedure: system treatment and surgery