Trial · NCT07911449
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial objective response rate (iORR) | Assessed every 12 weeks from the first day of SRS/SRT, up to 12 months | Percentage of participants with a best intracranial response of complete response (iCR) or partial response (iPR) according to RANO-BM on contrast-enhanced brain MRI (contrast-enhanced CT if MRI is not feasible). iCR: disappearance of all intracranial target and non-target lesions, no new lesions, no corticosteroids, clinically stable or improved. iPR: at least 30% decrease in the sum of longest diameters of target lesions (10 mm or larger) versus baseline, no new lesions, stable or decreased corticosteroids, clinically stable or improved. |
| Primary | Intracranial disease control rate (iDCR) | Assessed every 12 weeks from the first day of SRS/SRT, up to 12 months | Proportion of participants with a best intracranial response of iCR, iPR or stable disease (iSD) according to RANO-BM. |
| Secondary | Intracranial progression-free survival (iPFS) | From the first day of SRS/SRT until the date of first documented intracranial progression (RANO-BM) or death from any cause, whichever came first, assessed every 12 weeks up to 36 months | Time in months from the first day of SRS/SRT to first documented intracranial progression according to RANO-BM or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last adequate brain imaging assessment. Median estimated by the Kaplan-Meier method. |
| Secondary | Intracranial Progression-Free Survival Rate at 6 Months | 6 months after the first day of SRS/SRT | Percentage of participants alive and free of intracranial progression according to RANO-BM at 6 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Intracranial Progression-Free Survival Rate at 12 Months | 12 months after the first day of SRS/SRT | Percentage of participants alive and free of intracranial progression according to RANO-BM at 12 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Progression-free survival (PFS) | From the first day of SRS/SRT until the date of first documented progression at any site (RANO-BM or RECIST 1.1) or death from any cause, whichever came first, assessed every 12 weeks up to 36 months | Time in months from the first day of SRS/SRT to first documented progression at any site (intracranial according to RANO-BM or extracranial according to RECIST 1.1) or death from any cause, whichever occurs first. Participants without an event are censored at the date of the last adequate assessment. Median estimated by the Kaplan-Meier method. |
| Secondary | Progression-Free Survival Rate at 12 Months | 12 months after the first day of SRS/SRT | Percentage of participants alive and free of progression at any site (RANO-BM or RECIST 1.1) at 12 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Global health status/QoL is measured with the EORTC QLQ-C30 version 3.0 (items 29 and 30, 7-point scale). Raw scores are linearly transformed to a 0-100 scale according to the EORTC Scoring Manual; higher scores indicate better quality of life. Change from baseline is reported at t0 and t3. A change of \>= 10 points is considered clinically meaningful. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Functional Scale Scores at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Five functional scales of the EORTC QLQ-C30 version 3.0: physical, role, emotional, cognitive and social functioning. Each scale is scored 0-100 according to the EORTC Scoring Manual; higher scores indicate better functioning. A scale score is calculated if at least half of its items are answered. Each scale is reported separately as change from baseline at t0 and t3. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Symptom Scale and Single-Item Scores at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Three symptom scales (fatigue, nausea and vomiting, pain) and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties) of the EORTC QLQ-C30 version 3.0. Each is scored 0-100 according to the EORTC Scoring Manual; higher scores indicate a greater symptom burden. Each scale/item is reported separately as change from baseline at t0 and t3. |
| Secondary | Change From Baseline in EORTC QLQ-BN20 Brain Cancer-Specific Scale and Item Scores at t0 and t3 | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | The EORTC QLQ-BN20 brain cancer module (20 items) comprises four multi-item scales (future uncertainty, visual disorder, motor dysfunction, communication deficit) and seven single items (headaches, seizures, drowsiness, hair loss, itchy skin, weakness of both legs, bladder control). Each is scored 0-100 according to the EORTC Scoring Manual; higher scores indicate more symptoms or problems. Each scale/item is reported separately as change from baseline at t0 and t3. |
| Secondary | Completion Rate of EORTC QLQ-C30 and QLQ-BN20 Questionnaires | Baseline (within [7] days before the first radiotherapy fraction), t0 (at completion of radiotherapy), and t3 ([3] months after completion of radiotherapy) | Number and percentage of patients alive and on study at each time point who returned evaluable QLQ-C30 and QLQ-BN20 questionnaires. Questionnaires are self-administered in the validated Vietnamese versions. Reasons for missing questionnaires (death, clinical deterioration, loss to follow-up, administrative) are recorded. |
| Secondary | Number of Participants With Osimertinib-Related Adverse Events | From the first day of SRS/SRT, assessed every 4 weeks, up to 36 months | Number of participants with at least one osimertinib-related adverse event graded by CTCAE v5.0, including rash, mucositis, paronychia, diarrhoea, pneumonitis/interstitial lung disease, QTc prolongation, decreased left ventricular ejection fraction, keratitis, anaemia, neutropenia and thrombocytopenia. |
| Secondary | Number of Participants With Late SRS/SRT-Related Adverse Events | From day 91 after the last SRS/SRT fraction, assessed up to 36 months | Number of participants with at least one late radiation-related adverse event graded by CTCAE v5.0, including radiation necrosis and intracranial haemorrhage. |
| Secondary | Number of Participants With Acute SRS/SRT-Related Adverse Events | From the first fraction of SRS/SRT up to 90 days after the last fraction | Number of participants with at least one acute radiation-related adverse event graded by CTCAE v5.0, including fatigue, headache, nausea/vomiting, cerebral oedema and seizure. |
| Secondary | Overall Survival Rate at 12 Months | 12 months after the first day of SRS/SRT | Percentage of participants alive at 12 months after the first day of SRS/SRT, estimated by the Kaplan-Meier method. |
| Secondary | Overall survival (OS) | From the first day of SRS/SRT until the date of death from any cause, assessed up to 36 months | Time in months from the first day of SRS/SRT to death from any cause. Participants alive at the time of analysis are censored at the last date known to be alive. Median estimated by the Kaplan-Meier method. |
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.
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