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

Not Applicable

Active, not recruiting

• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Other: Margin-Based Radiotherapy planning; Other: Robust Radiotherapy planning

• Registration Number: NCT03552965
• Lead Sponsor: University of Arkansas

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.

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-29
• Study First Posted: 2018-06-12
• Study Start: 2018-06-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Margin-Based Radiotherapy Planning	Margin-Based Radiotherapy planning	This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Robust Radiotherapy Planning	Robust Radiotherapy planning	This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.

Primary Outcome Measures

Name	Time	Method
Grade of xerostomia	12 months after radiotherapy	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.
Prevalence of xerostomia	12 months after radiotherapy	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.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States