EORTC 2227-BTG: Lomustine with or without reirradiation for first progression of glioblastoma: a randomized phase III study (LEGATO)

Conditions

Glioblastoma

Brief summary

The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.

Detailed description

PFS. Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator, Objective and complete response per RANO criteria as assessed by the local investigator, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting, QDFS. A deterioration event is defined as ≥10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥10 point improvement) or death due to any cause, Neurocognitive functioning assessed by Mini Mental State Examination (MMSE)., Health utility, calculated from the collected patient-reported HRQoL data from the QLQ-C30 and patient demographics, Change scores. Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum), IQR, mean and standard deviation will be provided for all the other scales from the QLQ-C30, QLQ-BN20 and the item list (IL46).

Related papers

No related papers found yet.

Interventions

DRUGLOMUSTINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is OS defined as the number of days from date of enrolment to the date of death due to any cause.	—

Secondary

Measure	Time frame
PFS. Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator, Objective and complete response per RANO criteria as assessed by the local investigator, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting, QDFS. A deterioration event is defined as ≥10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥10 point improvement) or death due to any cause, Neurocognitive functioning assessed by Mini Mental State Examination (MMSE)., Health utility, calculated from the collected patient-reported HRQoL data from the QLQ-C30 and patient demographics, Change scores. Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum	—

Measure

Time frame

PFS. Events are progressions based on Response Assessment in Neuro Oncology (RANO) criteria as determined by the local investigator, Objective and complete response per RANO criteria as assessed by the local investigator, Safety according to the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0 for toxicity and Serious Adverse Event reporting, QDFS. A deterioration event is defined as ≥10-point worsening from baseline in the GHQ without further improvement (i.e., no subsequent ≥10 point improvement) or death due to any cause, Neurocognitive functioning assessed by Mini Mental State Examination (MMSE)., Health utility, calculated from the collected patient-reported HRQoL data from the QLQ-C30 and patient demographics, Change scores. Changes in HRQoL from baseline in the GHQ/QoL, fatigue, nausea/vomiting, physical, role and social functioning scale scores assessed over time will be evaluated descriptively. Descriptive summaries such as median, range (minimum, maximum

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Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Spain

Outcome results

None listed