Comparing 177Lu-DOTATATE treatment to supportive care after surgery for neuroendocrine liver metastases
An International Multicentre Randomized Unblinded Phase II Study Comparing Adjuvant Treatment With 177Lu-DOTATATE (Lutathera®) to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
This study is testing if a new treatment called 177Lu-DOTATATE can help people who have had surgery for certain types of neuroendocrine tumors in the liver live longer without their cancer coming back, compared to just getting supportive care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London) |
| Trial ID | NCT05987176 on ClinicalTrials.gov |
What this trial studies
This international, multi-centre, open, randomised, parallel-group phase II study aims to compare the effectiveness of adjuvant treatment with 177Lu-DOTATATE against best supportive care in patients who have undergone complete surgical removal of neuroendocrine liver metastases. Eligible participants include those with well-differentiated grade 1 or 2 neuroendocrine tumors in the stomach, pancreas, or gut. The primary objective is to assess overall disease-free survival at three years post-treatment, while secondary objectives include evaluating differences in disease-free survival in the liver and overall survival. Patients will be monitored for three years following treatment according to standard post-surgical follow-up protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with well-differentiated grade 1 or 2 gastroenteropancreatic neuroendocrine tumors who have undergone complete surgical resection of liver metastases.
Not a fit: Patients with poorly differentiated neuroendocrine tumors or those who have not undergone surgical resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with neuroendocrine liver metastases after surgery.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent prior to any study related procedures 2. Patients aged 18 years or older 3. ECOG / WHO performance status 0 or 1 4. Patients with well differentiated grade 1 or grade 2 (Ki67\<20%) GEP NET confirmed by histological criteria with the primary localisation in stomach, pancreas, or gut 5. Patients after R0 (complete macroscopic and microscopic resection) or R1 (complete macroscopic resection, microscopically positive resection margins) resection of neuroendocrine liver metastases confirmed by histological criteria 6. Patients with a primary tumour already resected or in whom the primary tumour has been resected synchronously with liver metastases 7. MRI scan prior to surgery (within 4 -6 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place) 8. Somatostatin receptor-based imaging (68Ga DOTA-TATE PET/CT prior to surgery (within 12 weeks) confirming liver metastases and no extrahepatic disease (except resectable perihilar lymph node involvement and/or primary tumour, if still in place) Exclusion Criteria: 1. Less than 4 weeks post-surgery, or any other medical treatment, including chemotherapy, radiotherapy, and intrahepatic therapy 2. High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma \[NEC\]) 3. After R2 (tumour debulking, macroscopically incomplete resection) resection of neuroendocrine liver metastases 4. Patients with non-resectable neuroendocrine liver metastases and/or non-resectable primary tumour and /or non-resectable perihilar lymph node metastases 5. Pregnancy 6. Subjects of childbearing potential (both male and female participants) not willing to use a combination of adequate contraceptive measures, e.g., oral contraceptives, IUD, barrier methods of contraception (condom or occlusive cap with spermicide) 7. Patients who have received prior systemic and/or liver-directed treatment for their metastatic NET other than somatostatin analogues 8. Hb concentration \<5.0 mmol/L (\<8.0 g/dL) 9. WBC \<2x109/L (2000/mm3) 10. Platelets \<75x109/L (75x103/mm3). 11. Total bilirubin \>3 x ULN. 12. Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range. 13. Uncontrolled congestive heart failure (NYHA II, III, IV). 14. Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN. 15. Prior external beam radiation therapy to more than 25% of the bone marrow. 16. Kidney failure with serum creatinine \>150 µmol/L (\>1.7 mg/dL) 17. Known hypersensitivity to somatostatin analogues
Where this trial is running
London
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Elena Ferrer
- Email: e.ferrer@imperial.ac.uk
- Phone: 020 33131362
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.