Surgery for metastatic pancreatic neuroendocrine tumors after initial treatment
Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
This study is testing if surgery to remove pancreatic neuroendocrine tumors and liver metastases can help people who have already had treatment and are doing well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | sunitinib, chemotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT04066322 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness and tolerability of surgical resection in patients with metastatic pancreatic neuroendocrine tumors (PanNET) who have undergone induction systemic treatment. Participants who achieve partial response or stable disease after systemic therapies will be considered for synchronous resection of both the primary tumor and liver metastases. The study aims to determine if this surgical approach can reduce tumor burden and improve survival outcomes. The decision to proceed with surgery will be made by the participants themselves, based on their treatment preferences.
Who should consider this trial
Good fit: Ideal candidates are patients with biopsy-proven pancreatic neuroendocrine tumors who have advanced disease with metastases and are willing to undergo systemic treatment.
Not a fit: Patients with undifferentiated neuroendocrine carcinoma, advanced carcinoid heart disease, or those unwilling to receive systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with metastatic pancreatic neuroendocrine tumors.
How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promising results in the surgical management of metastatic neuroendocrine tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: xianjun yu, MD
- Email: yuxianjun@fudanpci.org
- Phone: +86 21 64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.