Neuroendocrine Tumors Clinical Trial
Official title:
Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate
Randomized Phase II Trial in sstr2 Positive Tumors to Optimize the Interval Between Cycles of PRRT With 177lu-dotatate
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.
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