A PROSPECTIVE RANDOMIZED PHASE II STUDY TO ASSESS THE SCHEMAS OF RETREATMENT WITH LUTATHERA® ([177LU]LU-DOTA-TATE) IN PATIENTS WITH NEW PROGRESSION OF INTESTINAL WELL-DIFFERENTIATED NEUROENDOCRINE TUMOR

Conditions

Neuroendocrine tumor

Brief summary

Disease Control Rate (DCR) at 6 months from randomization (defined as Complete Response, Partial Response and Stable Disease from RECIST v1.1 with an evaluation every 2 months.

Detailed description

The Safety according to NCI-CTCAE v5.0, rPFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first., PFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or clinical progression or death from any cause, whichever occurs first, OS defined as the time from randomization until death from any cause., QoL assessed by EORTC QLQ-C30 and EORTC GI.NET21 questionnaires

Related papers

No related papers found yet.

Interventions

DRUGLutathera 370 MBq/mL solution for infusion

DRUGLysaKare 25 g/25 g solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease Control Rate (DCR) at 6 months from randomization (defined as Complete Response, Partial Response and Stable Disease from RECIST v1.1 with an evaluation every 2 months.	—

Secondary

Measure	Time frame
The Safety according to NCI-CTCAE v5.0, rPFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first., PFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or clinical progression or death from any cause, whichever occurs first, OS defined as the time from randomization until death from any cause., QoL assessed by EORTC QLQ-C30 and EORTC GI.NET21 questionnaires	—

Measure

Time frame

The Safety according to NCI-CTCAE v5.0, rPFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or death from any cause, whichever occurs first., PFS defined as the time from randomization until documented disease progression on radiological tumor assessment (as evaluated by an independent central review by radiologists blindly of the treatment assignments according to RECIST v1.1) or clinical progression or death from any cause, whichever occurs first, OS defined as the time from randomization until death from any cause., QoL assessed by EORTC QLQ-C30 and EORTC GI.NET21 questionnaires

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Countries

France

Outcome results

None listed