Trial · NCT03067610
Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
NCT03067610, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2022-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer. Trials, record NCT03067610. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03067610
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer
- NCT number
- NCT03067610
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 72 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Head and Neck Cancer, Carcinoma, Squamous Cell, Neoplasms, Oral, Neoplasms, Pharyngeal
- Interventions
- Intensity Modulated Radiation Therapy, chemotherapy
- First posted
- 2017-03-01
- Last updated
- 2022-03-17
- Results first posted
- 2022-03-17
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Solitary Elective Volume Recurrence | 2 years | The crude risk of 2-year solitary elective volume recurrence will be calculated among all patients who are followed for at least 2 years. Patients who die before 2 years without an SEVR will be included in the denominator. |
| Secondary | Quality of Life (QOL) Patient Reported Outcomes (PRO) | 12 months | Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI). EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms. MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning. |
| Secondary | Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5) | 2 years | Only adverse events (grade 3-5) assessed to be definitely, probably, or possibly related to protocol treatment up to 2 years post-treatment will be considered. This was measured according to NCI's CTCAE v4.0 toxicity criteria. |
| Secondary | Total Number of Participants With Gastrostomy Dependence | 2 years | The prevalence of gastrostomy use up to 2 years will be described. |
| Secondary | Patient Utilities | 2 years | The average patient utilities (derived from EQ-5D) from baseline up to 2 years from the end of treatment will be described. Changes in patient utility will be analyzed using generalized estimated equations (GEE). |
| Secondary | Overall Survival | 2 years | Overall survival will be calculated from the initiation of treatment using the Kaplan-Meier method. |
| Secondary | Progression-free Survival | 2 year | Progression-free survival will be calculated from the initiation of treatment. Progression is confirmed by biopsy, which will be used as the date of progression. |
| Secondary | Probability of Locoregional or Distant Tumor Failure | 2 years | The percentage of patients with locoregional or distant failure within 2 years of treatment will be estimated using cumulative incidence statistics, with death serving as the competing risk. Cumulative incidence refers to the estimated risk/probability of tumor failure within 2 years of treatment, either locoregional recurrence or distant metastasis, accounting for the competing risk of death. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Solitary Elective Volume Recurrence | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life (QOL) Patient Reported Outcomes (PRO) | 12 months | score on a scale | MEAN | |
| SECONDARY | Number of Participants With Definite, Possible, and Probable Protocol-related Toxicities (Grade 3-5) | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Number of Participants With Gastrostomy Dependence | 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Patient Utilities | 2 years | Collected data were not considered valid due to software limitations as it was not available to auto-calculate the data as proposed by our EMR | ||
| SECONDARY | Overall Survival | 2 years | Reported the percentage of the total patient population who survived to 2 years post-treatment. | percentage of patients | NUMBER |
| SECONDARY | Progression-free Survival | 2 year | Percentage of the total patient population with progression-free survival 2 years post treatment | percentage of patients | NUMBER |
| SECONDARY | Probability of Locoregional or Distant Tumor Failure | 2 years | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Solitary Elective Volume Recurrence | Radiation Therapy | 0 | Participants | ||
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort Baseline | EORTC QLQ30 global | 71.4 | Standard Error 2.3 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 3 Month | EORTC QLQ30 global | 76.9 | Standard Error 2.6 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 6 Month | EORTC QLQ30 global | 79.2 | Standard Error 2.8 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 12 Month | EORTC QLQ30 global | 85.9 | Standard Error 2.3 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort Baseline | EORTC QLQ30 physical fcn | 90.3 | Standard Error 1.7 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 3 Month | EORTC QLQ30 physical fcn | 87.4 | Standard Error 2.3 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 6 Month | EORTC QLQ30 physical fcn | 90.3 | Standard Error 2.4 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort 12 Month | EORTC QLQ30 physical fcn | 93.0 | Standard Error 1.8 | score on a scale |
| Quality of Life (QOL) Patient Reported Outcomes (PRO) | Total Cohort Baseline | EORTC QLQ30 role fcn | 81.9 | Standard Error 3.0 | score on a scale |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radiation Therapy | 72 | |
| Overall Study | COMPLETED | Radiation Therapy | 72 | |
| Overall Study | NOT COMPLETED | Radiation Therapy | 0 |
Source ClinicalTrials.gov
Adverse events403
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Radiation Therapy | 1 | 72 | |
| other | abdominal pain | Gastrointestinal disorders | Radiation Therapy | 18 | 72 | |
| other | abscess of chin | General disorders | Radiation Therapy | 1 | 72 | |
| other | Acid Reflex | Gastrointestinal disorders | Radiation Therapy | 11 | 72 | |
| other | acne vulgaris | Skin and subcutaneous tissue disorders | Radiation Therapy | 1 | 72 | 1 |
| other | Acneform rash | Skin and subcutaneous tissue disorders | Radiation Therapy | 1 | 72 | 1 |
| other | agitated | Psychiatric disorders | Radiation Therapy | 1 | 72 | 1 |
| other | Albumin Decreased | Metabolism and nutrition disorders | Radiation Therapy | 1 | 72 | 1 |
| other | alkaline phosphate decreased | Investigations | Radiation Therapy | 3 | 72 | 3 |
| other | alkaline phosphatase increased | Investigations | Radiation Therapy | 2 | 72 | 2 |
1 to 10 of 403Source ClinicalTrials.gov
See all 403 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radiation Therapy | 1 | 72 |
| Total, other adverse events | Radiation Therapy | 65 | 72 |
| Total, serious adverse events | Radiation Therapy | 35 | 72 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT03067610
GET https://conductscience.org/api/trials/v1/NCT03067610/results?page=2