Lu-DOTATATE Treatment in Patients With 68Ga-DOTATATE Somatostatin Receptor Positive Neuroendocrine Tumours

Official Title

A Prospective Single-Arm, Multi-Centre, Study of the Efficacy and Safety of Lutetium-177 Octreotate (Lu-DOTATATE) Treatment With Individualized Dosimetry in Patients With 68Ga-DOTATATE Identified Somatostatin Receptor Positive Neuroendocrine Tumours

Summary:

This is a prospective single arm, multicentre study will evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumours who has positive Somatostatin receptor identified by 68Ga-DOTATATE. 195 patients will be enrolled totally. Patient who has progressed with neuroendocrine tumour will be evaluated by the tumour 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.

Trial Description

Primary Outcome:

• The proportion of patients progression-free using RECIST 1.1 criteria

• The overall response rate as determined by structural imaging using RECIST criteria.
• The biochemical response rate (as defined by biochemical responses: serum chromogranin A and 24 hr urinary 5HIAA).
• The acute and late adverse effects of Lu-DOTATATE (177Lu) using CTCAE Version 4.03
• Overall survival
• The Quality of Life (QoL) in patients treated with Lu-DOTATATE (177Lu)

View this trial on ClinicalTrials.gov