Metastases, Neuroendocrine Tumors, Surgery
Conditions
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.
Interventions
PROCEDUREsystem 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.
OTHERsystem treatment
to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment.
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| number of Patients die from any cause during 90 days after operation | 5 years | — |
| progression-free survival in subgroup analysis | 5 years | liver metastasis type, grade, extrahepatic metastasis |
Countries
China
Contacts
Primary Contactxianjun yu, MD
Backup ContactHeli Gao
Outcome results
None listed