Clinical trial NCT03552965: Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: xerostomia
Robust photon radiotherapy
Margin based radiotherapy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Grade of Xerostomia
timeFrame: Baseline
measure: Grade of Xerostomia
timeFrame: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
measure: Grade of Xerostomia
timeFrame: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
measure: Grade of Xerostomia
timeFrame: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
measure: Grade of Xerostomia
timeFrame: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
measure: Prevalence of Xerostomia
timeFrame: Baseline
measure: Prevalence of Xerostomia
timeFrame: Month 3 (i.e., 3 months (+/- 30 days) after baseline visit)
measure: Prevalence of Xerostomia
timeFrame: Month 6 (i.e., 6 months (+/- 30 days) after baseline visit)
measure: Prevalence of Xerostomia
timeFrame: Month 9 (i.e., 9 months (+/- 30 days) after baseline visit)
measure: Prevalence of Xerostomia
timeFrame: Month 12 (i.e., 12 months (+/- 30 days) after baseline visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mausam Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: