NCT03454763

Optimizing the Interval Between Cycles of PRRT with 177lu-dotatate in Sstr2 Positive Tumors

Randomized Phase II Trial in Sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT with 177lu-dotatate

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 618 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate

Detailed description

The main objective of this randomized phase II comparative study is to evaluate the Progression Free survival (PFS) and the safety as co-primary objective of two different schedule of administrations of 177lu-dotatate: intensive (every 5 weeks) vs no intensive (every 8-10 weeks) The secondary objectives are DCR, the late toxicity, OS and dosimetry. Patients with any tumor histotype documented as sst2-positive in pre-study period will be enrolled in the study. The study will include a total of 618 planned patients. They will be randomly assigned to receive 5 cycles of PRRT at intervals of 5 or 8-10 weeks between cycles.

Conditions

• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	PRRT every 5 weeks	PRRT (radiolabelled somatostatin analogues) every 5 weeks for 5 cycles
DRUG	PRRT every 8-10 weeks	PRRT (radiolabelled somatostatin analogues) every 8-10 weeks for 5 cycles

Timeline

• Start date: 2016-05-26
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2018-03-06
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy