Trial · NCT06809322
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) by local assessment | ~7.7 years and 10.5 years from first patient in | Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS. |
| Secondary | PFS by local assessment | ~7.7 years and 10.5 years from first patient in | Progression-free survival (PFS) will be defined as the number of days from date of enrolment to the date of earliest disease progression based on Response Assessment (RANO 2.0) or to the date of death due to any cause, if disease progression did not occur (the date of progression or death or censoring - date of enrolment + 1). Patients who received new anti-cancer therapy or cancer-related surgery or radiotherapy prior to progression or death will not be censored at the last assessment where the patient was documented as progression free prior to the new anti-cancer therapy or cancer-related surgery or radiotherapy, instead progression after start of new therapy or surgery will be considered a valid event for PFS. |
| Secondary | Progression-free survival (PFS) from the start of radiotherapy | ~7.7 years and 10.5 years from first patient in | Progression-free survival from the start of radiotherapy will be defined as the number of days from date of start of radiotherapy till progression or censoring with the same rules as for PFS. |
| Secondary | Overall Survival | ~7.7 years and 10.5 years from first patient in | Overall survival (OS) will be defined as the number of days from date of enrolment to the date of death due to any cause (the date of death or censoring - date of enrolment +1). If a subject has not died, the data will be censored at the last date documented to be alive. Patients still alive (or not known to have died before the cutoff date) or lost to follow-up are censored at the last date known to be alive. |
| Secondary | Overall Response | ~7.7 years and 10.5 years from first patient in | All patients included in the study must be assessed for their overall response treatment based on RANO 2.0 criteria at each assessment of the disease, from the start of study treatment until disease progression , even if there is a major protocol treatment deviation, if they are ineligible, or not followed/ /re-evaluated. Each patient will be assigned one of the following categories: complete response (CR), partial response (PR), minor response (MR, applicable only to non-enhancing disease), stable disease (SD), Equivocal progressive disease (EqPD), progressive disease (PD), early death (ED) or not evaluable (NE). Early death is defined as any death occurring before the first per protocol time point of tumour re-evaluation. |
| Secondary | Time to next intervention | ~7.7 years and 10.5 years from first patient in | Time to next intervention (TTNI) will be defined as the number of days calculated from the date of enrolment until the commencement of further anticancer treatment following vorasidenib or placebo discontinuation (including surgery or radiotherapy), irrespective of whether progression was documented. If a patient does not initiate further anticancer therapy TTNI will be censored at the date of death or last known alive date. |
| Secondary | Adverse events | ~7.7 years from first patient in | All adverse events (AEs) will be recorded; the investigator will assess whether those events are drug related (reasonable possibility, no reasonable possibility) and this assessment will be recorded in the database for all AEs. The collection period for all AEs will start up to 4 weeks prior to enrolment and until 30 days after the end of treatment. After those 30 days, only SAEs related to study drug or study participation have to be collected. All AEs must be followed until resolution or stabilization. |
| Secondary | Health-related Quality of Life QLQ-C30. | ~7.7 years from first patient in | Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: EORTC QLQ-C30 |
| Secondary | Health-related Quality of Life QLQ-BN20. | ~7.7 years from first patient in | Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: EORTC QLQ-BN20. |
| Secondary | Health-related Quality of Life IADL-BN32 | ~7.7 years from first patient in | Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: IADL-BN32 |
| Secondary | Health-related Quality of Life item list 46 (IL46) | ~7.7 years from first patient in | Health related quality of life (HRQoL) will be measured using a questionnaire which will be completed by the patient: item list 46 (IL46) |
| Secondary | Neurocognitive function HVLT-R - Part A Free recall | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: HVLT-R - Part A Free recall |
| Secondary | Neurocognitive function TMT - Part A | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: TMT - Part A |
| Secondary | Neurocognitive function TMT - Part B | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: TMT - Part B |
| Secondary | Neurocognitive function COWA | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: COWA |
| Secondary | Neurocognitive function MOS scale | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: MOS scale |
| Secondary | Neurocognitive function HVLT-R - Part B Delayed recall HVLT-R - Part C Delayed recognition | ~7.7 years from first patient in | Neurocognitive function will be measured using a questionnaire which will be completed by the patient: HVLT-R - Part B Delayed recall HVLT-R - Part C Delayed recognition |
| Secondary | Seizure activity | ~7.7 years from first patient in | Seizure activity will be measured using will be measured using a questionnaire which will be completed by the physician: Seizure Control Composite Score Index |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT06809322/registered