Trial · NCT07908914
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
NCT07908914, Not applicable, Not yet recruiting, Affidea Nu-med Center of Oncological DIagnostics and Therapy
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors. Trials, record NCT07908914. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07908914
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
- NCT number
- NCT07908914
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 426 participants, estimated
- Lead sponsor
- Affidea Nu-med Center of Oncological DIagnostics and Therapy
- Conditions
- Solid Tumor
- Interventions
Homogeneous External-Beam Radiotherapy, 20 Gy in Five Fractions, Homogeneous External-Beam Radiotherapy, 25 Gy in Five Fractions, LATTICE Radiotherapy, 20 Gy With a Simultaneous Integrated Boost to 66.7 Gy in Five Fractions
- First posted
- 2026-11-02
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07908914
GET https://conductscience.org/api/trials/v1/NCT07908914/registered?page=2