Margin-Based Vs. Robust Photon Radiotherapy Planning in IMRT of HN-SQCC
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 6/30/2018 |
| Start Date: | June 19, 2018 |
| End Date: | July 1, 2020 |
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
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.
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.
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.
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.
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
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Jose Penagaricano, MD
Phone: 501-686-8274
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
Click here to add this to my saved trials
