Trial · NCT05664464
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PFS-6 | 6 months | progression-free survival at 6 months |
| Secondary | PFS | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | progression-free survival |
| Secondary | OS | From date of randomization until the date of death from any cause, assessed for at least 6 months and up to 42 months | overall survival |
| Secondary | OS-12 | 12 months | overall survival at 12 months |
| Secondary | SFS | From date of randomization until the date of first documented seizure or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | Seizure-free survival |
| Secondary | SFS-6 | 6 months | Seizure-free survival at 6 months |
| Secondary | QoL | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and Brain Tumor Module BN20 (EORTC QLQ-C30/BN20) |
| Secondary | Symptom burden | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) questionnaire, Neurologic assessment in neuro-oncology (NANO) scale |
| Secondary | Quality of life of an informal caregiver | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | CareGiver Oncology Quality of Life (CarGO-QOL) questionnaire |
| Secondary | Cognitive Functioning | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | Montreal Cognitive Assessment (MoCA) test |
| Other | Overall response rate | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | as defined by RANO |
| Other | Tumor glutamate levels | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | determined by MRI spectroscopy |
| Other | General condition | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | Karnofsky Performance Status (KPS) |
| Other | Anticonvulsant drug use and steroid use | From date of randomization until the date of first documented tumor progression or date of death from any cause, whichever came first, assessed for a minimum of 6 months and up to 42 months | Documentation of drug name, dose, frequency and duration of intake |
| Other | Subgroup survival analyses | From date of randomization until the date of first documented tumor progression, or death from any cause, whatever occurs first, assessed for at least 6 months and up to 42 months | PFS compared between subgroups segregated by baseline parameters including age, extent of resection, KPS, MGMT promotor methylation status, steroid intake, presence or absence of seizures, tumor volumes, glutamate levels determined by MR spectroscopy, and molecular subtypes |
| Other | Subgroup survival analyses | From date of randomization until the date of death from any cause, assessed for at least 6 months and up to 42 months | OS compared between subgroups segregated by baseline parameters including age, extent of resection, KPS, MGMT promotor methylation status, steroid intake, presence or absence of seizures, tumor volumes, glutamate levels determined by MR spectroscopy, and molecular subtypes |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05664464/registered