Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrin… (NCT02743741) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumors
Canada195 participantsStarted 2016-07-15
Plain-language summary
This is a prospective single arm, multicenter study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumor will be evaluated by the tumor board first and eligible patients will undergo diagnostic Ga 68 PET scan. Patients who showed Somatostatin will undergo 4 cycles of Lu-DOTATATE treatment. Dose adjustment for Cycle 2-4 will be made based on individualized dosimetry, as well as creatinine clearance and hematological parameters. Patients will be evaluated progression free survival at 12 months from last dose. Patients who are negative for somatostatin will not receive 68Ga-DOTATATE treatment but will be followed until progression and acts as control group.
Who can participate
SexALL
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Inclusion criteria
✓. Biopsy-proven neuroendocrine tumor
✓. ECOG performance status ≤ 2
✓. Ki-67 index ≤ 30%
✓. Evidence of progressive disease demonstrated by imaging within six months prior to study enrollment as defined by RECIST v1.1.
✓. Adequate lab parameters within 2 weeks prior to enrollment:
✓. Adequate liver function tests within 2 weeks prior to enrollment:
✓. Signed informed consent
✓. Patients with extensive bone metastases (e.g. \>25% of bone marrow involvement are eligible but requires careful monitoring of hematological reserve
Exclusion criteria
✕. Life expectancy \<12 weeks
✕. An option for curative surgical or medical therapy or local liver embolization is feasible
✕. Candidate for curative and/or debulking surgical resections
✕
What they're measuring
1
The proportion of patients progression-free using RECIST 1.1 criteria