EORTC 2334-BTG: [177Lu]Lu-DOTATATE for recurrent MENingioma (LUMEN-1): a randomized phase II study

Conditions

Recurrent Meningioma without local treatment options (Surgery or Radiotherapy)

Brief summary

The primary endpoint in this phase II study is progression-free survival (PFS) computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.

Detailed description

Best overall response (BOR, defined as complete response (CR), minor response (MR) or partial response (PR) during study treatment). Objective response (CR/MR/PR) rate and median CR/MR/PR duration. Complete response rate and median CR duration computed by MRI based on RANO meningioma response criteria as assessed by the local investigator., Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)., Safety (CTCAE v.5.0) and tolerability ([177Lu]Lu-DOTATATE only)., Change from baseline in HRQoL in terms of the global QoL, cognitive functioning, social functioning and fatigue at week 24., Change of neurological function (NANO scale) from baseline during study treatment.

Related papers

No related papers found yet.

Interventions

DRUGLutathera 370 MBq/mL solution for infusion

DRUGHYDROXYCARBAMIDE

DRUGSUNITINIB

DRUGBEVACIZUMAB

DRUGEVEROLIMUS

DRUGOCTREOTIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint in this phase II study is progression-free survival (PFS) computed based on MRI-based RANO meningioma response criteria as assessed by the local investigator.	—

Secondary

Measure	Time frame
Best overall response (BOR, defined as complete response (CR), minor response (MR) or partial response (PR) during study treatment). Objective response (CR/MR/PR) rate and median CR/MR/PR duration. Complete response rate and median CR duration computed by MRI based on RANO meningioma response criteria as assessed by the local investigator., Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)., Safety (CTCAE v.5.0) and tolerability ([177Lu]Lu-DOTATATE only)., Change from baseline in HRQoL in terms of the global QoL, cognitive functioning, social functioning and fatigue at week 24., Change of neurological function (NANO scale) from baseline during study treatment.	—

Measure

Time frame

Best overall response (BOR, defined as complete response (CR), minor response (MR) or partial response (PR) during study treatment). Objective response (CR/MR/PR) rate and median CR/MR/PR duration. Complete response rate and median CR duration computed by MRI based on RANO meningioma response criteria as assessed by the local investigator., Overall survival (OS), OS probability at 6 (OS6) and 12 months (OS12), median OS (mOS)., Safety (CTCAE v.5.0) and tolerability ([177Lu]Lu-DOTATATE only)., Change from baseline in HRQoL in terms of the global QoL, cognitive functioning, social functioning and fatigue at week 24., Change of neurological function (NANO scale) from baseline during study treatment.

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Countries

Austria, Denmark, France, Germany, Norway, Spain

Outcome results

None listed