Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment

Surgery Clinical Trial

— RMPanNET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04066322
• Other study ID #: CSPAC-26
• Status: Recruiting
• Start date: August 25, 2019
• Est. completion date: July 25, 2025

Study information

• Verified date: September 2019
• Source: Fudan University
• Contact: xianjun yu, MD
• Phone: +86 21 64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 25, 2025
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastases
• Neuroendocrine Tumors
• Surgery

Intervention

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

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of Patients die from any cause during 90 days after operation		5 years
Other	progression-free survival in subgroup analysis	liver metastasis type, grade, extrahepatic metastasis	5 years
Primary	progression-free survival		5 years
Secondary	overall survival		5 years
Secondary	Number of Postoperative morbidity	Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation	Up to 90 days after operation
Secondary	number of Postoperative mortality		Up to 90 days after operation