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

NCT ID: NCT03552965

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2025-02-01

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Margin-Based Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.

Group Type: ACTIVE_COMPARATOR

Margin-Based Radiotherapy planning

Intervention Type: OTHER

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area

Robust Radiotherapy Planning

This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.

Group Type: ACTIVE_COMPARATOR

Robust Radiotherapy planning

Intervention Type: OTHER

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

Interventions

Robust Radiotherapy planning

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

Intervention Type: OTHER

Margin-Based Radiotherapy planning

Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area

Intervention Type: OTHER

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mausam Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

217585

Identifier Type: -

Identifier Source: org_study_id