Receptor radionuclide therapy with 177Lu-DOTATOC (177Lu- edotreotide or 177Lu-octreotide) in SSTR positive patients: a multicenter, prospective, phase II trial

Conditions

Bronchopulmonary and other NETs, NET, NETs retreated with PRRT, Neuroendocrine Tumor, Other SSTR-positive tumours, Pheochromocytomas and paragangliomas

Brief summary

The primary endpoint is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) at the 1st planned evaluation

Detailed description

Safety was evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months, PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation, Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off, Quality of life will be evaluated through validated standardised data collection forms from the EORTC QLQ-C30 questionnaire. QoL will be collected at baseline, at every cycle of treatment start and at end of treatment

Related papers

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Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) at the 1st planned evaluation	—

Secondary

Measure	Time frame
Safety was evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months, PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation, Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off, Quality of life will be evaluated through validated standardised data collection forms from the EORTC QLQ-C30 questionnaire. QoL will be collected at baseline, at every cycle of treatment start and at end of treatment	—

Measure

Time frame

Safety was evaluated according to version 5.0 CTC-AE. Safety is defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months, PFS is defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation, Overall survival is defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off, Quality of life will be evaluated through validated standardised data collection forms from the EORTC QLQ-C30 questionnaire. QoL will be collected at baseline, at every cycle of treatment start and at end of treatment

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Countries

Italy

Outcome results