A Multicentre, Stratified, Open, Randomized, Comparator-controlled, Parallel-group Phase III Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
The purpose of the research is to compare the effect of treatment with radioactive Octreotate (Lutatheria) versus the standard-of-care Octreotide (Sandostatin) in patients with neuroendocrine tumors of the small bowel and pancreas. In addition to this main study, there is also a substudy portion of this research. The purpose of the substudy is to see how quickly Lutathera is distributed in a patients internal organs, to monitor how it is processed, and to measure its excretion from the body (also known as pharmacokinetics). Additionally, the substudy will accurately measure the radiation dose that has been absorbed by the patient's organs and tumors (known as Dosimetry).These investigations are needed so that we can better understand how Lutathera works and how safe it is.
- drug : Octreotide LAR
- drug : 177Lu-DOTA0-Tyr3-Octreotate
Phase: Phase 3
Ages Eligible For Study:
1. Presence of metastasized or locally advanced, inoperable (curative intent) at enrollment time, histologically proven, midgut carcinoid tumour (to be centrally confirmed). 2. Ki67 index ? 20% (to be centrally confirmed). 3. Patients on Octreotide LAR at a fixed dose of 20 mg or 30 mg at 3-4 weeks intervals for at least 12 weeks prior to randomization in the study. 4. Patients ?18 years of age. 5. Patients must have progressive disease based on RECIST Criteria, Version 1.1 while receiving an uninterrupted fixed dose of Octreotide LAR (20-30 mg/3-4 weeks). Disease progression must be centrally confirmed. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than 3 years from the date of randomization. The most recent scan must not be older than 4 weeks from the date of randomization. Both scans must be obtained while the patient is receiving the same fixed dose of Octreotide LAR (20-30 mg/3-4 weeks) with the following exceptions; 1) it is acceptable if the oldest scan is obtained within 12 weeks of the patient receiving a fixed dose regimen of Octreotide LAR (20-30 mg/3-4 weeks); AND 2) it is acceptable for either scan to be obtained before or during the time a patient receiving a fixed dose of Octreotide LAR has switched to an equivalent dose of short acting Octreotide for up to 6 weeks in order to obtain an OctreoScan«, provided the patient returns to the Octreotide LAR fixed dose after the OctreoScan« has been obtained. 6. Confirmed presence of somatostatin receptors on all target lesions (for target/non-target/measurable lesions definition see žAppendix 2, Section 1 and 2, RECIST Criteria, Version 1.1) documented by CT/MRI scans, based on positive OctreoScan« imaging within 24 weeks prior to randomization in the study (to be centrally confirmed). The OctreoScan« should be one that was performed while the patient was on a fixed dose of Octreotide LAR. If a patient has had an OctreoScan« performed while Octreotide LAR treatment-na´ve, the patient must have a repeat OctreoScan« performed after 3 months of Octreotide LAR treatments before entering the clinical study to prove that the index lesions or new lesions still meet the criteria for inclusion. It is acceptable to have patients temporarily switched to Octreotide s.c. (up to six weeks) in order to obtain an OctreoScan«, provided they return to the same fixed dose of Octreotide LAR prior to the scan. 7. The tumour uptake observed in each target lesion (for target/non-target/measurable lesions definition see žAppendix 2, Sections 1 and 2, RECIST Criteria, Version 1.1) using OctreoScan« must be ? normal liver uptake observed on planar imaging (to be centrally confirmed) (žAppendices 5 and 6). 8. Karnofsky Performance Score (KPS)>=60. 9. Presence of at least 1 measurable site of disease. 10. [Applicable only for France] All patients included in the trial must be affiliated with a social security regime or be a beneficiary of the same in order to be included in the study.