Optimizing the Interval Between Cycles of PRRT With 177lu-dotatate in sstr2 Positive Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuroendocrine Tumors
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: comparativeMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 object...
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.
Tracking Information
- NCT #
- NCT03454763
- Collaborators
- Not Provided
- Investigators
- Study Chair: Giovanni Paganelli, MD IRST IRCCS Principal Investigator: Stefano Severi, MD IRST IRCCS
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