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NCT03552965

Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC

Completed NA Results posted Last updated 2 September 2025
What this trial tests

NA trial testing Robust Radiotherapy planning in Squamous Cell Carcinoma of the Head and Neck in 23 participants. Completed in 1 February 2025.

Timeline
19 June 2018
Primary endpoint
9 March 2024
1 February 2025

Quick facts

Lead sponsorUniversity of Arkansas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment23
Start date19 June 2018
Primary completion9 March 2024
Estimated completion1 February 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Arkansas

Who can join

21 and older, any sex, with Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Grade of Xerostomia Primary · Baseline

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

GroupValue95% CI
Margin-Based Radiotherapy Planning1.14± 0.378
Robust Radiotherapy Planning1.17± 0.577
Grade of Xerostomia Primary · Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

GroupValue95% CI
Margin-Based Radiotherapy Planning2.00± 0.894
Robust Radiotherapy Planning2.91± 1.136
Grade of Xerostomia Primary · Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

GroupValue95% CI
Margin-Based Radiotherapy Planning2.5± 0.577
Robust Radiotherapy Planning2.33± 1.225
Grade of Xerostomia Primary · Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

GroupValue95% CI
Margin-Based Radiotherapy Planning1.83± 0.753
Robust Radiotherapy Planning2.33± 1.000
Grade of Xerostomia Primary · Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

Self reported dry mouth using Late Effects Normal Tissue Task Force -Subjective, Objective, Management, Analytic (LENT/SOMA) scale. LENT/SOMA measures xerostomia in 4 stages. This ranges from Stage 1 "occasional dryness" through Stage 4 "complete dryness, debilitating". Lower stage values indicate a more favorable outcome than higher stage values.

GroupValue95% CI
Margin-Based Radiotherapy Planning2.00± 0.707
Robust Radiotherapy Planning2.38± 1.188
Prevalence of Xerostomia Primary · Baseline

Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

GroupValue95% CI
Margin-Based Radiotherapy Planning15.5± 23.76242
Robust Radiotherapy Planning14.1346± 17.87095
Prevalence of Xerostomia Primary · Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)

Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

GroupValue95% CI
Margin-Based Radiotherapy Planning45.625± 30.68744
Robust Radiotherapy Planning64.3182± 15.0142
Prevalence of Xerostomia Primary · Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)

Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

GroupValue95% CI
Margin-Based Radiotherapy Planning60.0000± 23.68412
Robust Radiotherapy Planning54.8611± 29.91815
Prevalence of Xerostomia Primary · Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)

Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

GroupValue95% CI
Margin-Based Radiotherapy Planning31.6667± 31.38139
Robust Radiotherapy Planning54.0278± 24.57274
Prevalence of Xerostomia Primary · Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

Self reported dry mouth using University of Michigan's Xerostomia Questionnaire (XQ). This questionnaire has 8 questions that measure the degree to which xerostomia is affecting quality of life. Patients rate each item on a scale from 0 to 10. Higher score denotes worse xerostomia. To analyze the XQ, scores on its 8 items will be summed for each subject at each time point to produce an overall XQ score whose values theoretically can range from 0 to 80; it will be treated as a continuous variable. Lower values indicate a more favorable outcome than higher values.

GroupValue95% CI
Margin-Based Radiotherapy Planning50.75± 30.29284
Robust Radiotherapy Planning38.4375± 26.69897

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to Month 12 (i.e., 12 months (+/- 30 days) after baseline visit). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Margin-Based Radiotherapy Planning
Serious: 2/10 (20%)
Deaths: 1/10
Robust Radiotherapy Planning
Serious: 5/13 (38%)
Deaths: 1/13

Serious adverse events (15 terms)

ReactionSystemMargin-Based Radiotherapy …Robust Radiotherapy Planning
Lymphocyte count decreasedInvestigations——
SepsisInfections and infestations——
AnemiaBlood and lymphatic system disorders——
DehydrationMetabolism and nutrition disorders——
FatigueGeneral disorders——
HyponatremiaMetabolism and nutrition disorders——
NauseaGastrointestinal disorders——
Neutrophil count decreasedInvestigations——
Psychiatric disorders - Other, specifyPsychiatric disorders——
Skin infectionInfections and infestations——
VomitingGastrointestinal disorders——
White blood cell decreasedInvestigations——
Pharyngeal mucositisRespiratory, thoracic and mediastinal disorders——
Acute kidney injuryRenal and urinary disorders——
Death NOSGeneral disorders——
Other adverse events (79 terms — click to expand)

ReactionSystemMargin-Based Radiotherapy …Robust Radiotherapy Planning
FatigueGeneral disorders——
Lymphocyte count decreasedInvestigations——
Alkaline phosphatase increasedInvestigations——
AnemiaBlood and lymphatic system disorders——
Dry mouthGastrointestinal disorders——
DysgeusiaNervous system disorders——
White blood cell decreasedInvestigations——
Dermatitis radiationInjury, poisoning and procedural complications——
ConstipationGastrointestinal disorders——
DysphagiaGastrointestinal disorders——
HyponatremiaMetabolism and nutrition disorders——
Platelet count decreasedInvestigations——
AnorexiaMetabolism and nutrition disorders——
Gastrointestinal disorders - Other, specifyGastrointestinal disorders——
HyperglycemiaMetabolism and nutrition disorders——
HypoalbuminemiaMetabolism and nutrition disorders——
HypocalcemiaMetabolism and nutrition disorders——
HypokalemiaMetabolism and nutrition disorders——
NauseaGastrointestinal disorders——
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Neutrophil count decreasedInvestigations——
Sore throatRespiratory, thoracic and mediastinal disorders——
VomitingGastrointestinal disorders——
Creatinine increasedInvestigations——
DehydrationMetabolism and nutrition disorders——
DiarrheaGastrointestinal disorders——
DyspneaRespiratory, thoracic and mediastinal disorders——
HypermagnesemiaMetabolism and nutrition disorders——
HypertensionVascular disorders——
HypothyroidismEndocrine disorders——
InsomniaPsychiatric disorders——
Investigations - Other, specifyInvestigations——
Mucositis oralGastrointestinal disorders——
Oral painGastrointestinal disorders——
Respiratory, thoracic and mediastinal disorders - Other, specifyRespiratory, thoracic and mediastinal disorders——
Skin infectionInfections and infestations——
Sleep apneaRespiratory, thoracic and mediastinal disorders——
Weight lossInvestigations——
GGT increasedInvestigations——
Gastroesophageal reflux diseaseGastrointestinal disorders——

Most-reported serious reactions: Lymphocyte count decreased, Sepsis, Anemia, Dehydration, Fatigue, Hyponatremia, Nausea, Neutrophil count decreased.

Data from ClinicalTrials.gov NCT03552965 adverse events section.

Sponsor's own description

This is a research study to evaluate the quality of life and amount of dry mouth experienced as a result of radiotherapy in subjects who have squamous cell carcinoma of the head and neck (HN-SQCC). This study will compare the side effects experienced based on the method to plan radiotherapy, Margin Based or Robust.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Squamous Cell Carcinoma of the Head and Neck

Currently open trials in the same condition.

Other University of Arkansas trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing