Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

NCT04066322 | Unknown

• 1 other identifier: CSPAC-26
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors; Metastases; Surgery

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  5 years

Secondary Outcomes (3)

• overall survival

  5 years

• Number of Postoperative morbidity

  Up to 90 days after operation

• number of Postoperative mortality

  Up to 90 days after operation

Other Outcomes (2)

• number of Patients die from any cause during 90 days after operation

  5 years

• progression-free survival in subgroup analysis

  5 years

Study Arms (2)

system treatment

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

Other: 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

Interventions

system treatment and surgery PROCEDURE

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.

Also known as: resection of primary and metastatic tumors

system treatment and Surgery

system treatment OTHER

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

system treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center

You may qualify if:

• Biopsy-proven neuroendocrine tumor
• primary site in pancreas
• Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
• curative intent of all therapies possible
• ECOG 0-2

You may not qualify if:

• Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
• functioning NET or advanced carcinoid heart disease
• part of hereditary syndrome, such as MEN1, VHL
• do not willing to receive systemic treatment
• diagnosed with other cancer within 5 years

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Neoplasm Metastasis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

xianjun yu, MD

CONTACT

+86 21 64175590; yuxianjun@fudanpci.org

Heli Gao

CONTACT

+86 21 64175590; gaoheli@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: August 25, 2019
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2025
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)