Trial · NCT04883281
A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
NCT04883281, Phase 2, Completed, University of Texas Southwestern Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer. Trials, record NCT04883281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04883281
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Study of Daily Adaptive Radiotherapy to Better Organ-at-Risk Doses in Head and Neck Cancer
- NCT number
- NCT04883281
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Head and Neck Cancer
- Interventions
- Intensity modulated radiation therapy (IMRT) with or without chemotherapy, cisplatin, cetuximab, or carboplatin-paclitaxel
- First posted
- 2021-05-12
- Last updated
- 2026-03-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Xerostomia Questionnaire (XQ) | 1 year | 1-year score on the Xerostomia Questionnaire (XQ) to determine the difference in chronic xerostomia between patients treated with conventional INRT versus ML DART INRT. The XQ score at one year will be compared between the arms using a two-sided t test. |
| Secondary | Development of acute and chronic toxicity in patients treated with and without DART | 1 year | Incidence of acute grade 2+ radiation dermatitis, acute and chronic grade 3+ dysphagia, acute grade 3+ mucositis, and chronic grade 2+ soft tissue and osteonecrosis. Each toxicity endpoint will be compared between the arms using a Fisher exact test. |
| Secondary | Risk of locoregional recurrence with and without DART | 1 year | Cumulative incidence of locoregional recurrence, as confirmed by biopsy. The cumulative incidence of locoregional and distant failure will be estimated using cumulative incidence statistics, with death serving as the competing risk. The two arms will be compared using Gray's test. |
| Secondary | Patient reported outcomes | 1 year | Patient Reported Outcomes (PRO): EORTC QLQ-30 Global Score, EORTC HN 35 Pain and Senses Scores, MDADI Composite Score Each of the patient reported outcomes are single numeric scores that are collected at baseline, 1, 3, 6, and 12 months from treatment. Patients with disease recurrence will be excluded. At each individual time point, the differences between the arms in the changes of these outcomes between baseline to that timepoint will be compared using a t-test and analyzed longitudinally using generalized estimated equations (GEE). |
Source ClinicalTrials.gov
Outcomes0
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40833933 | DERIVED |
Source PubMed
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04883281
GET https://conductscience.org/api/trials/v1/NCT04883281/registered