Trial · NCT07908914
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Target-Symptom Response at Week 8 | Baseline before randomization and days 49-63 after final fraction; fixed death/rescue cutoff day 63. For delayed, unstarted or incomplete treatment, use the planned final-fraction date. | Participant-reported target-symptom numeric rating scale (NRS): 0 means no symptom and 10 means worst imaginable severity. The symptom and wording are frozen before randomization; baseline NRS is at least 4. Response requires an NRS reduction of at least 2 points within days 49-63 and being alive and free of protocol-defined index-lesion rescue through day 63 after the final fraction. Death or rescue on or before day 63 is nonresponse regardless of earlier improvement. If multiple valid scores occur, use the score closest to day 56; ties use the earlier score. Participants alive and rescue-free through day 63 without a valid in-window score have missing outcomes handled by multiple imputation, rather than automatic nonresponse. Events after day 63 do not alter classification. Analysis retains all randomized participants under assigned treatment. |
| Secondary | Percentage of Participants With Target-Symptom Response at Weeks 4 and 12 | Baseline and days 21-35 and 70-98 after final fraction, with death/rescue cutoffs at days 35 and 98. Planned final-fraction date applies if treatment is delayed, not started or incomplete. | At each landmark, response requires a participant-reported target-symptom numeric rating scale reduction of at least 2 points from the baseline score, using the same frozen symptom wording and 0-10 scale as the primary outcome. Participants must be alive and free of protocol-defined index-lesion rescue through the fixed end of the relevant window: day 35 for week 4 and day 98 for week 12. Death or rescue by that cutoff is nonresponse, irrespective of earlier improvement. Apply the primary nearest-target-date rule (target days 28 and 84; ties use the earlier value). An alive, rescue-free participant without a valid in-window score has a missing outcome. Proportions are reported separately at each landmark. |
| Secondary | Percentage of Participants With Durable Target-Symptom Response Through Week 12 | Week 8 (days 49-63) and week 12 (days 70-98) after final fraction; fixed final death/rescue cutoff day 98. Planned final-fraction date applies if treatment is delayed, not started or incomplete. | Binary outcome requiring the participant to meet the protocol target-symptom response definition at both week 8 and week 12, with no protocol-defined index-lesion rescue. Each response requires a reduction of at least 2 points on the frozen 0-10 numeric rating scale from baseline and survival without rescue through the corresponding window-end cutoff. Death or rescue through day 98 precludes durable response. A valid score is required in each landmark window; missing scores are distinguished from known death/rescue failures. The outcome is reported in the randomized population, not only among week-8 responders. |
| Secondary | Change in Global Quality of Life on the Quality of Life Questionnaire Core 15 Palliative | Baseline before randomization and weeks 4 (days 21-35), 8 (days 49-63) and 12 (days 70-98) after final fraction; week 8 is the main assessment. | Change from baseline in the global quality-of-life score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative (EORTC QLQ-C15-PAL), a 15-item questionnaire for advanced cancer. Scoring follows the current manual and transforms scales to 0-100; higher global scores indicate better quality of life, so positive change indicates improvement. Week 8 is the main time point; weeks 4 and 12 are supportive. Analysis uses participants with evaluable patient-reported outcome measures, with a multiple-imputation sensitivity analysis. Reports must be the participant's own; telephone administration requires an authorized, validated mode. |
| Secondary | Change in Physical Functioning on the Quality of Life Questionnaire Core 15 Palliative | Baseline before randomization and weeks 4 (days 21-35), 8 (days 49-63) and 12 (days 70-98) after final fraction; week 8 is the main assessment. | Change from baseline in the physical-functioning score of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative (EORTC QLQ-C15-PAL). Scoring follows the current manual, with scales transformed to 0-100. Higher physical-functioning scores indicate better function, so positive change indicates improvement. Week 8 is the main time point; weeks 4 and 12 are supportive. Analysis uses participants with evaluable patient-reported outcome measures, with a multiple-imputation sensitivity analysis. The participant supplies the report; a caregiver cannot provide a proxy questionnaire. |
| Secondary | Patient Global Impression of Change in the Target Symptom | Weeks 4 (days 21-35), 8 (days 49-63) and 12 (days 70-98) after final fraction. | Distribution across seven Patient Global Impression of Change categories and percentage reporting "much better" or "very much better". At each contact the participant rates change in the target symptom since treatment began: very much worse, much worse, minimally worse, no change, minimally better, much better, or very much better. The latter two categories define response. More favorable categories indicate greater benefit. Results are reported separately at weeks 4, 8 and 12. This measure supplements the target-symptom numeric rating scale and does not replace it. |
| Secondary | Participant-Reported Symptomatic Adverse Events | Baseline through week 12 after final fraction, including scheduled post-treatment contacts and weeks 4, 8 and 12. | Prespecified core and site-specific attributes from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The core module covers pain, fatigue, decreased appetite, nausea, vomiting and shortness of breath. One site-specific module is selected from the locked operations manual before randomization and cannot change because of assigned treatment. Official current-language instruments are used; selected attributes are reported separately according to their official response scales rather than as an invented total score. Baseline values and trajectories through week 12 are analyzed in participants with evaluable patient reports. |
| Secondary | Percentage of Participants With Clinically Significant Treatment Intolerance or Treatment-Related Morbidity | From the first actual radiotherapy fraction through 90 days after the actual final fraction of the assigned course. | Composite occurrence of any: permanent discontinuation or omission of an assigned fraction because of an adverse event or clinical deterioration at least possibly related to radiotherapy; an adverse-event-related interruption preventing completion within 7 calendar days; a treatment-related serious adverse event or unplanned hospitalization; a treatment-related grade 3 or higher nonhematologic adverse event; clinical grade 3 or higher tumor lysis syndrome at least possibly related to radiotherapy; or treatment-related death. Events are graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0. Each component, maximum grade, attribution, timing, resolution and organ-system category is reported separately. Safety summaries use both all-treated and all-randomized denominators. |
| Secondary | Percentage of Participants Completing the Assigned Five-Fraction Course Without a Major Deviation | End of the assigned radiotherapy course: normally within 7 calendar days from fraction 1; maximum 10 calendar days after a documented permitted interruption. | Completion of all five assigned radiotherapy fractions within 7 calendar days from fraction 1, or within the protocol-permitted maximum of 10 calendar days after a documented medical, public-holiday or technical interruption, without a protocol-defined major deviation. Participants are analyzed by randomized assignment; treatment non-initiation and incomplete courses are retained in the randomized denominator. Completion dates, interruptions and deviations are recorded. |
| Secondary | Time to First Index-Lesion Rescue Treatment | From randomization through month 12. | Time from randomization to the first unplanned local intervention to the index lesion for inadequate symptom control, progression, a complication or imminent risk. Qualifying rescue includes re-irradiation, surgery, ablation, embolization, stenting, drainage, cementoplasty, stabilization or another invasive local procedure. Diagnostic biopsy alone and escalation of supportive medication alone are not rescue. Rescue dates, indication, urgency and procedure are recorded. Clinically indicated rescue is never delayed for outcome assessment. |
| Secondary | Overall Survival | From randomization to death or last known alive, assessed through 24 months. | Time from randomization to death from any cause. Participants alive are censored at the last known date alive. Survival is summarized at 3, 6, 12 and 24 months and by median survival where estimable. Vital status may be obtained at visits, by telephone, from treating clinicians, medical records or legally permitted registries; the source and date are recorded. Cause of death is not required for this outcome. |
| Secondary | Progression-Free Survival | From randomization through month 12; estimates at months 3, 6 and 12. | Time from randomization to first documented progression according to Response Evaluation Criteria in Solid Tumors, version 1.1, at the index lesion or another site; unequivocal clinical progression recorded by the treating oncology team; or death from any cause. Starting new anticancer therapy without documented progression is not automatically an event and triggers record review and classification under the prespecified statistical analysis plan. Summaries are at 3, 6 and 12 months. Imaging frequency and reason are described. Sensitivities use interval censoring between last nonprogressive and first progressive assessments, scheduled-imaging windows, an imaging-progression-or-death definition and alternative censoring at new systemic therapy. |
| Secondary | Cumulative Incidence of Clinically Relevant Index-Lesion Failure | From randomization through month 12; cumulative incidence at months 3, 6 and 12. | First imaging or clinical progression of the index lesion leading to rescue treatment, unplanned hospitalization, major deterioration of target symptoms or death attributed primarily to local progression. Local imaging progression is assessed by Response Evaluation Criteria in Solid Tumors, version 1.1, where applicable. Attribution of death to the index lesion requires documented review by the Principal Investigator using available clinical evidence and without allocation information where feasible. Death without evidence that the index lesion was the principal cause is a competing event. Cumulative incidence is reported at 3, 6 and 12 months in the randomized population. |
| Secondary | Percentage Change From Baseline in Index-Lesion Gross Tumor Volume | Baseline and week 12 (day 84 ±14), with supportive month 6 (day 182 ±30) and month 12 (day 365 ±45) assessments after final fraction. | Percentage change in index-lesion gross tumor volume, calculated as 100 times the difference between follow-up and baseline volumes, divided by baseline volume. Negative values indicate reduction. Week 12 is the main assessment; months 6 and 12 are supportive where evaluable. The main scan-evaluable population consists of randomized participants alive with valid baseline and in-window follow-up imaging and no protocol-defined index-lesion rescue before that scan. Deaths, rescue and reasons for missing imaging are reported by arm. A treatment-policy sensitivity includes post-rescue images with rescue indicators; a worst-rank sensitivity ranks death and morphology-altering rescue unfavorably before observed changes. These survivor/scan-evaluable analyses are not intention-to-treat treatment effects. |
| Secondary | Radiographic Response of the Index Lesion and Overall Measurable Disease | Week 12 (day 84 ±14 after final fraction) and best response through month 12; month 6 and 12 imaging is obtained where clinically appropriate and evaluable. | Index-lesion and overall measurable-disease response according to Response Evaluation Criteria in Solid Tumors, version 1.1, at week 12 and best response through month 12. Categories and objective response are reported where disease is measurable. The main population comprises randomized participants alive with valid baseline and follow-up imaging and no protocol-defined index-lesion rescue before the relevant scan. Rescue-related imaging non-evaluability and missingness are reported by arm. Post-rescue imaging is retained only in the treatment-policy sensitivity with an explicit rescue indicator; deaths and morphology-altering rescue are unfavorable in the prespecified worst-rank sensitivity. Scan-evaluable results are not interpreted as intention-to-treat treatment effects. |
| Secondary | Days Alive and Out of Hospital Through Day 90 | The fixed 90-calendar-day interval beginning on the date of randomization: days 0-89, with randomization date as day 0. | Number of calendar days alive without an inpatient overnight during the fixed 90-day interval from randomization date (inclusive) to randomization date plus 90 days (exclusive; days 0-89). The range is 0-90; higher is better. All-cause planned and unplanned inpatient stays count. Outpatient radiotherapy and same-day emergency care without admission are not inpatient stays. The day of death and later days contribute zero; dead and inpatient time are not subtracted twice. Admission, discharge and death dates are retained. Unknown daily status is missing, not presumed out of hospital. All randomized participants are analyzed as allocated, including nonstarters. Delays, discontinuation, rescue and subsequent treatment do not reset the interval. Mortality and hospitalization components are reported separately. |
| Secondary | Acute Treatment-Related Adverse Events by Severity | From the first actual radiotherapy fraction through 90 days after the actual final fraction of the assigned course. | Incidence of treatment-related adverse events (AEs), including separate percentages with grade 2 or higher and grade 3 or higher events, graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0. Relationship is recorded as unrelated, unlikely, possibly, probably or definitely related to protocol radiotherapy. Events are tabulated by maximum grade, organ-system category, relationship, seriousness, timing and resolution. All serious AEs, grade-5 events and suspected tumor lysis syndrome are recorded and reported separately. Baseline abnormalities are recorded to distinguish new or worsening AEs. Safety summaries use all-treated and all-randomized denominators. |
| Secondary | Late Treatment-Related Adverse Events and Morbidity | Onset more than 90 days after the actual final radiotherapy fraction through month 12 or death; ongoing related or serious events are followed until resolution, stabilization, death or loss to follow-up. | Incidence and maximum severity of late treatment-related adverse events or morbidity, including grade 2 or higher and grade 3 or higher events. Late events have onset more than 90 days after the actual final radiotherapy fraction and are graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0. Site-specific events include ulceration or necrosis, bleeding, fistula or perforation, airway compromise, pneumonitis, myelopathy or neuropathy, fracture, edema or mass-effect flare, and tumor lysis syndrome. Attribution, seriousness, onset, resolution and interventions are recorded; all serious and grade-5 events are described separately. Related or serious events are followed until resolution, stabilization, death or loss to follow-up. Actual treatment dates, exposure and observation duration are retained, with all-treated and all-randomized summaries. |
| Secondary | International Consensus Pain Response in the Pain-Target Subgroup | Weeks 4 (days 21-35), 8 (days 49-63) and 12 (days 70-98) after final fraction. | International Consensus Pain Response Endpoint classification using treated-site pain and oral morphine-equivalent dose (OMED), in participants whose target symptom was frozen as pain before randomization. Complete response is pain score zero without increased OMED. Partial response is a reduction of at least 2 pain-score points without increased OMED, or an OMED reduction of at least 25% without increased pain. Pain progression and indeterminate categories follow the consensus algorithm. Conversion rules are fixed prospectively. Categories and response are reported separately at each landmark. This is a nonconfirmatory secondary endpoint. The algorithm originates from bone-metastasis trials; its application to other anatomical sites is an adaptation and is not claimed to be uniformly validated across all tumors. |
| Other | Longitudinal Target-Symptom Severity and Area Under the Score Curve | End of radiotherapy (day 0), day 7 (+/-1), day 14 (+/-3), day 28 (+/-7), day 56 (+/-7) and day 84 (+/-14), up to day 98. Day 0 is the final fraction, or the planned final-fraction date if treatment is delayed, not started or incomplete. | Repeated participant-reported target-symptom numeric rating scale scores and area under the longitudinal score curve. The same symptom, verbatim wording and recall period are frozen before randomization. The 11-point scale runs from 0, no symptom, to 10, worst imaginable severity; lower scores indicate lower symptom burden. Measurements are obtained at end of radiotherapy, day 7 and weeks 2, 4, 8 and 12. Analyses use longitudinal models and joint longitudinal-survival summaries, with missingness and assessment mode described; no caregiver proxy score is accepted. |
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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