Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

NCT ID: NCT04066322

Last Updated: 2019-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-25

Study Completion Date

2025-07-25

Brief Summary

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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

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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.

Conditions

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Neuroendocrine Tumors Metastases Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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system treatment

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

system treatment

Intervention Type 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 and Surgery

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

system treatment and surgery

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

system treatment

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

Intervention Type OTHER

Other Intervention Names

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resection of primary and metastatic tumors

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xian-Jun Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xianjun yu, MD

Role: CONTACT

+86 21 64175590

Heli Gao

Role: CONTACT

+86 21 64175590

Facility Contacts

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XianJun Yu, M.D., Ph.D.

Role: primary

+86-21-6417-5590

Other Identifiers

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CSPAC-26

Identifier Type: -

Identifier Source: org_study_id

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