Trial · NCT07908914
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 31 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Other | Time to First Clinically Meaningful Target-Symptom Improvement | From randomization through the week-12 assessment (day 84 ±14 after final fraction). | Time from randomization to the first recorded reduction of at least 2 points from baseline on the frozen participant-reported target-symptom numeric rating scale. Scores range from 0, no symptom, to 10, worst imaginable severity; reduction indicates improvement. Assessments are retained with exact dates. This is an exploratory timing analysis rather than the fixed week-8 responder outcome, which has separate death/rescue rules. |
| Other | Target-Symptom Response Using Alternative Prespecified Improvement Thresholds | End of radiotherapy through week 12 after final fraction. | Exploratory response proportions using reductions from baseline of at least 1, 2 or 3 points and at least 30% or 50% on the frozen participant-reported target-symptom numeric rating scale. The scale runs from 0, no symptom, to 10, worst imaginable severity. Each threshold is reported separately and is not combined into a new response score. Symptom-specific responder definitions are explored separately. These analyses do not replace the primary 2-point response definition or its fixed day-63 death/rescue rule. |
| Other | Quality-of-Life Scale Trajectories and Deterioration | Baseline through month 12 after final fraction. | Scale-specific longitudinal analyses of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative. The 15-item questionnaire covers global quality of life, physical and emotional functioning and key symptom scales. Each scale is scored separately according to the authorized manual and transformed to 0-100: higher functional/global scores are better, whereas higher symptom scores indicate greater burden. Exploratory analyses include trajectories, response using prespecified minimally important differences and time to deterioration. These analyses supplement the separately registered main global quality-of-life and physical-functioning change outcomes; no invented total score combines scales. |
| Other | Concordance Between Participant-Reported and Clinician-Graded Symptomatic Adverse Events | Baseline through week 12 after final fraction. | Exploratory comparison of participant-reported symptom attributes from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with clinician grading under the National Cancer Institute Common Terminology Criteria for Adverse Events, version 6.0. Core and frozen site-specific attributes are followed over time. Agreement and disagreement are assessed for corresponding symptoms and attributes; participant and clinician measures are retained separately and are not averaged into a composite score. |
| Other | Exploratory Volumetric Response Categories | Week 12 (day 84 ±14), month 6 (day 182 ±30) and month 12 (day 365 ±45) after final fraction. | Mutually exclusive exploratory categories based on percentage change in index-lesion gross tumor volume (delta V), calculated as 100 multiplied by (follow-up volume minus baseline volume), divided by baseline volume. Complete disappearance: delta V equals minus 100%. Major reduction without complete disappearance: minus 100% less than delta V and delta V at most minus 65%. Moderate reduction: minus 65% less than delta V and delta V at most minus 30%. Stable volume: minus 30% less than delta V and delta V less than plus 30%. Increase: delta V at least plus 30%. Thus exactly 30% reduction is a response, and exactly 30% increase is an increase. These custom exploratory categories are not validated response criteria and do not replace Response Evaluation Criteria in Solid Tumors, version 1.1. Frequencies are reported separately from continuous volume change in the prespecified scan-evaluable population. |
| Other | Spatial Patterns of Local Failure | Through month 12 after treatment. | Exploratory mapping of local failures to planned high-dose peaks, low-dose valleys, tumor periphery, necrotic regions and areas of undercoverage required by organ-at-risk constraints. Imaging-evaluable local failures are described according to their spatial relationship to the delivered/planned dose distribution. This is separate from the randomized-population cumulative incidence of clinically relevant local failure. |
| Other | Restricted Mean Overall Survival Through 6 and 12 Months | From randomization through 6 months and through 12 months. | Restricted mean overall survival from randomization through the prespecified 6- and 12-month horizons. Overall survival ends at death from any cause; living participants are censored at the last known date alive. Restricted mean survival summarizes the area under the overall-survival curve up to each horizon and is reported separately from the median and landmark survival probabilities. |
| Other | Restricted Mean Progression-Free Survival Through 6 and 12 Months | From randomization through 6 months and through 12 months. | Restricted mean progression-free survival from randomization through the 6- and 12-month horizons. Events are first documented progression according to Response Evaluation Criteria in Solid Tumors, version 1.1, unequivocal clinical progression, or death. Starting new anticancer therapy without documented progression is not automatically an event. Restricted mean survival summarizes the area under the progression-free-survival curve up to each horizon, retaining the protocol's imaging-ascertainment and censoring sensitivity analyses. |
| Other | Survival Conditional on Symptom or Imaging Assessment Landmarks | Prespecified symptom/imaging landmarks through month 12. | Exploratory conditional survival summaries among participants alive at each prespecified patient-reported symptom or imaging landmark. The protocol distinguishes these landmark populations from the full randomized cohort. Overall survival and progression-free survival retain their separately specified event definitions and are reported separately; conditioning is not interpreted as an intention-to-treat treatment effect. |
| Other | Healthcare Utilization and Acute-Care Contacts | From randomization during the fixed 90-calendar-day interval [randomization date, randomization date plus 90 days), and, where available, through month 12. | Exploratory counts of hospital admissions and inpatient nights, emergency-department visits, unplanned outpatient acute-care contacts, invasive index-lesion procedures and re-irradiation. Each utilization type is reported separately with exact dates. Same-day emergency care without admission is separate from inpatient stays. Counts are collected from randomization during the fixed first 90-day interval and, where available, through month 12. Delayed, unstarted or discontinued treatment, rescue and subsequent therapy do not reset this clock. Days alive and out of hospital during the first 90 days after randomization remain a separate secondary endpoint. |
| Other | Subsequent Systemic Anticancer Therapy and Local Procedures | From randomization through month 12. | Occurrence, type and dates of subsequent systemic therapy and index-lesion re-irradiation, surgery, ablation, embolization, drainage or other local procedures. Systemic therapy and each local intervention type are summarized separately. Protocol-defined index-lesion rescue remains separately recorded and is incorporated into the registered rescue and symptom outcomes when its criteria are met. |
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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