Status:
RECRUITING
Comparison of Adjuvant Treatment With 177Lu-DOTATATE to Best Supportive Care in Patients After Resection of Neuroendocrine Liver Metastases
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
The Taylor Family 2010 Charitable Trust
Novartis/AAA
Conditions:
Neuroendocrine Tumor G1 (NET G1)/Carcinoid
Neuroendocrine Tumor Grade 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An international multi-centre, open, randomised, parallel-group phase II study comparing adjuvant treatment with 177Lu-DOTATATE to best supportive care in patients after complete surgical removal of n...
Detailed Description
There will be 2 arms: arm A consisting of best supportive care and arm B, the experimental treatment. Randomisation will be 1:1 as soon as possible after the liver surgery. The control arm will consi...
Eligibility Criteria
Inclusion
- Written informed consent prior to any study related procedures
- Patients aged 18 years or older
- ECOG / WHO performance status 0 or 1
- 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
- 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
- Patients with a primary tumour already resected or in whom the primary tumour has been resected synchronously with liver metastases
- 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)
- 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
- Less than 4 weeks post-surgery, or any other medical treatment, including chemotherapy, radiotherapy, and intrahepatic therapy
- High grade neuroendocrine tumours (G3 NET, or neuroendocrine carcinoma \[NEC\])
- After R2 (tumour debulking, macroscopically incomplete resection) resection of neuroendocrine liver metastases
- Patients with non-resectable neuroendocrine liver metastases and/or non-resectable primary tumour and /or non-resectable perihilar lymph node metastases
- Pregnancy
- 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)
- Patients who have received prior systemic and/or liver-directed treatment for their metastatic NET other than somatostatin analogues
- Hb concentration \<5.0 mmol/L (\<8.0 g/dL)
- WBC \<2x109/L (2000/mm3)
- Platelets \<75x109/L (75x103/mm3).
- Total bilirubin \>3 x ULN.
- Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range.
- Uncontrolled congestive heart failure (NYHA II, III, IV).
- Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN.
- Prior external beam radiation therapy to more than 25% of the bone marrow.
- Kidney failure with serum creatinine \>150 µmol/L (\>1.7 mg/dL)
- Known hypersensitivity to somatostatin analogues
Key Trial Info
Start Date :
August 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2029
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05987176
Start Date
August 2 2024
End Date
March 30 2029
Last Update
August 9 2024
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0HS