Evaluation of the addition of Everolimus to 177Lu-DOTATATE in the treatment of grades 2 and 3 refractory meningioma: a phase IIb clinical trial

Conditions

meningioma

Brief summary

PFS-6 from the start of treatment according to the RANO criteria

Detailed description

1) OS-12. Overall Survival, defined as the time from the date of inclusion to the date of death from any cause., 2) Tumor growth rate, defined as the product of the two largest diameters of the target lesion from the MRI at M3 or M6 compared to the diameters of the lesion at baseline., 3) PFS-6. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 4) OS-12. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 5) Number and types of grade 1, 2, 3 or 4 adverse events according to the CTCAE (Common Terminology Criteria for Adverse Events) classification per patient, from the start of treatment until 180 days after the end of the last treatment cycle., 6) HRQoL, assessed using the EORTC QLQ-C30 questionnaire at inclusion (V1) and at 6 months (V7).

Related papers

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Interventions

DRUGEverolimus PUREN 2

DRUG5 mg Tabletten

DRUGEverolimus beta 5 mg Tabletten

DRUGLutathera 370 MBq/mL solution for infusion

DRUGEverolimus PUREN 5 mg Tabletten

DRUGEverolimus beta 2

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS-6 from the start of treatment according to the RANO criteria	—

Secondary

Measure	Time frame
1) OS-12. Overall Survival, defined as the time from the date of inclusion to the date of death from any cause., 2) Tumor growth rate, defined as the product of the two largest diameters of the target lesion from the MRI at M3 or M6 compared to the diameters of the lesion at baseline., 3) PFS-6. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 4) OS-12. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 5) Number and types of grade 1, 2, 3 or 4 adverse events according to the CTCAE (Common Terminology Criteria for Adverse Events) classification per patient, from the start of treatment until 180 days after the end of the last treatment cycle., 6) HRQoL, assessed using the EORTC QLQ-C30 questionnaire at inclusion (V1) and at 6 months (V7).	—

Measure

Time frame

1) OS-12. Overall Survival, defined as the time from the date of inclusion to the date of death from any cause., 2) Tumor growth rate, defined as the product of the two largest diameters of the target lesion from the MRI at M3 or M6 compared to the diameters of the lesion at baseline., 3) PFS-6. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 4) OS-12. Dose delivered to the tumor (dosimetry) will be calculated on at least 2 skull scans with 177Lu-DOTATATE SPECT-CT (D1 and D7), after the first cycle of 177Lu-DOTATATE., 5) Number and types of grade 1, 2, 3 or 4 adverse events according to the CTCAE (Common Terminology Criteria for Adverse Events) classification per patient, from the start of treatment until 180 days after the end of the last treatment cycle., 6) HRQoL, assessed using the EORTC QLQ-C30 questionnaire at inclusion (V1) and at 6 months (V7).

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Countries

France

Outcome results

None listed