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

• ClinicalTrials.gov Identifier: NCT03552965
• Recruitment Status: Enrolling by invitation
• First Posted: June 12, 2018
• Last Update Posted: June 9, 2021
• Sponsor: University of Arkansas
• Information provided by (Responsible Party): University of Arkansas

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.

Condition or disease	Intervention/treatment	Phase
Squamous Cell Carcinoma of the Head and Neck	Other: Robust Radiotherapy planning; Other: Margin-Based Radiotherapy planning	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prospective Randomized Pilot Clinical Trial of Margin-Based Vs. Robust Photon Radiotherapy Planning in Intensity-Modulated Radiation Therapy of Squamous-Cell Carcinoma of the Head and Neck
• Actual Study Start Date: June 19, 2018
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: July 1, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Margin-Based Radiotherapy Planning; This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.	Other: Margin-Based Radiotherapy planning; Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
Active Comparator: Robust Radiotherapy Planning; This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.	Other: Robust Radiotherapy planning; Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue

Outcome Measures

Primary Outcome Measures :

1. Grade of xerostomia [ Time Frame: 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.
2. Grade of xerostomia [ Time Frame: 3 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.
3. Grade of xerostomia [ Time Frame: 6 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.
4. Grade of xerostomia [ Time Frame: 9 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.
5. Grade of xerostomia [ Time Frame: 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.
6. Prevalence of xerostomia [ Time Frame: 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.
7. Prevalence of xerostomia [ Time Frame: 3 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.
8. Prevalence of xerostomia [ Time Frame: 6 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.
9. Prevalence of xerostomia [ Time Frame: 9 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.
10. Prevalence of xerostomia [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

• Principal Investigator: Thomas Kim, MD; University of Arkansas

More Information

• Responsible Party: University of Arkansas
• ClinicalTrials.gov Identifier: NCT03552965
• Other Study ID Numbers: 217585
• First Posted: June 12, 2018
• Last Update Posted: June 9, 2021
• Last Verified: June 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Arkansas:

xerostomia; Robust photon radiotherapy; Margin based radiotherapy

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site