NCT03552965 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2025-09-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Grade of Xerostomia

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outcome · POSTED

Grade of Xerostomia

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outcome · POSTED

Grade of Xerostomia

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outcome · POSTED

Grade of Xerostomia

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outcome · POSTED

Grade of Xerostomia

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outcome · POSTED

Prevalence of Xerostomia

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outcome · POSTED

Prevalence of Xerostomia

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outcome · POSTED

Prevalence of Xerostomia

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outcome · POSTED

Prevalence of Xerostomia

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outcome · POSTED

Prevalence of Xerostomia

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histological documentation of Squamous-Cell Carcinoma of the Head and Neck (HN-SQCC) * Older than 21 years of age * Subject is eligible for routine chemo-radiotherapy for treatment of HN-SQCC * Informed consent is obtained * Karnofsky performance of at least 70 points Exclusion Criteria: * Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential must agree to refrain from breast feeding and practice adequate contraception * Unable to comply with study procedures * Use of saliva stimulating prescription drugs such as Evoxac or Salagen * Unable to receive standard chemotherapy
healthy Volunteers: false
minimum Age: 21 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
intervention Names
Other: Margin-Based Radiotherapy planning
label
Margin-Based Radiotherapy Planning
type
ACTIVE_COMPARATOR
description
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
intervention Names
Other: Robust Radiotherapy planning
label
Robust Radiotherapy Planning
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Robust Radiotherapy Planning
description
Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
name
Robust Radiotherapy planning
type
OTHER
arm Group Labels
Margin-Based Radiotherapy Planning
description
Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
name
Margin-Based Radiotherapy planning
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 23
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Grade of Xerostomia
time Frame
Baseline
description
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.
measure
Grade of Xerostomia
time Frame
Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
description
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.
measure
Grade of Xerostomia
time Frame
Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
description
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.
measure
Grade of Xerostomia
time Frame
Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
description
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.
measure
Grade of Xerostomia
time Frame
Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
description
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.
measure
Prevalence of Xerostomia
time Frame
Baseline
description
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.
measure
Prevalence of Xerostomia
time Frame
Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
description
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.
measure
Prevalence of Xerostomia
time Frame
Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
description
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.
measure
Prevalence of Xerostomia
time Frame
Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
description
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.
measure
Prevalence of Xerostomia
time Frame
Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)

Full study description

brief Summary: 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.
detailed Description: This is a prospective randomized pilot clinical trial, stratified by primary tumor site, to evaluate the degree of xerostomia and quality of life (QOL) in subjects with HN-SQCC treated with radiation therapy under margin-based and robust radiotherapy treatment plans. Margin-based plans will use both biological (biological optimization) and physical objectives whereas robust planning will use physical objectives for sparing of the parotid glands. Intensity-modulated radiation therapy (IMRT) and standard chemotherapy will be used. QOL (quality of life) will be measured using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 questionnaire and EORTC QLQ-H\&N35 (head and neck) module before radiotherapy (baseline) and then 3, 6, 9 and 12 months after radiotherapy. Xerostomia will be measured in study subjects using two patient-reported scoring systems completed by each subject before radiotherapy and then 3, 6, 9, and 12 months after radiotherapy: Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) LENT/SOMA grading system and the University of Michigan's Xerostomia Questionnaire (XQ). The data collected by this randomized pilot clinical trial will be used to inform the design of, and decision-making for, future larger studies that seek to compare different methods of radiotherapy planning in the treatment of HN-SQCC.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice