Clinical trial · Interventional
Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors
Peptide Receptor Radionuclide Therapy (PRRT) with Radiolabelled Somatostatin Analogue 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors, 18F-2-fluoro-2-deoxy-D-glucose (FDG)-PET Negative Patients: a Prospective Phase II Randomized Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment target not reached
Summary
Brief summary (as posted)
This is a randomized phase II non-comparative study. Patients with gastroenteropancreatic Neuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDG negative will be enrolled in the study and will be randomly assigned to 2 different dosages (total activity of 25.9 GBq and total activity of 18.5 GBq).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 177Lu-DOTATATE 18.5 GBq activity | Drug | — | UNRESOLVED |
| 177Lu-DOTATATE 25.9 GBq activity | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 177Lu-DOTATATE 25.9 GBq activity
- description
- 177Lu-DOTATATE 25.9 GBq activity. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)
- interventionNames
- Drug: 177Lu-DOTATATE 25.9 GBq activity
- type
- EXPERIMENTAL
- label
- 177Lu-DOTATATE 18.5 GBq activity
- description
- 177Lu-DOTATATE 18.5 GBq activity. Total activity of 18.5 GBq 100 mCi for 5 cycles, every 6 ± 2 weeks (500 mCi)
- interventionNames
- Drug: 177Lu-DOTATATE 18.5 GBq activity
Primary outcomes (2)
- measure
- Disease control rate (DCR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67 index \<= 20%. * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1.criteria) * Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST 1.1. criteria * Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour * FDG PET negative (SUV less than 2.5) * Concomitant somatostatin analogs assumption is allowed * Life expectancy greater than 6 months. * ECOG performance status \<2 * Adequate haematological, liver and renal function: haemoglobin \>= 9 g/dL, absolute neutrophil count (ANC) \>= 1.5 x 109 /L, platelets \>= 100 x 109 /L, bilirubin ≤1.5 X upper normal limit (UNL) , Alanine transaminase (ALT) \<2.5 X UNL (\< 5 X UNL in presence of liver metastases), creatinine \< 2 mg/dL. * If female of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. * Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: * Ki 67 index \> 20 % * FDG PET positive at least in one documented lesion with a SUV more than 2.5 * Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy). * Patients treated with previous radiometabolic therapy with an adsorbed dose to the kidney more than 25 Gy and 1,5 Gy for the bone marrow. * All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade \<= 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE) * Participation in another clinical trial with any investigational agents within 30 days prior to study screening. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * History of allergic reactions attributed to compounds of similar chemical or biologic composition
References
Publications (0)
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