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Radiation Planning
Robust vs. Margin-Based Radiotherapy for Head and Neck Cancer
N/A
Waitlist Available
Led By Mausam Patel, MD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance of at least 70 points
Histological documentation of Squamous-Cell Carcinoma of the Head and Neck (HN-SQCC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after radiotherapy
Awards & highlights
Study Summary
This trial will compare the side effects of two types of radiation therapy for squamous cell carcinoma of the head and neck.
Who is the study for?
This trial is for adults over 21 with a type of cancer called HN-SQCC, who are fit enough for standard chemo-radiotherapy. They must be able to follow the study procedures and not use certain saliva-stimulating drugs. Pregnant or breastfeeding women cannot participate unless they agree to use contraception.Check my eligibility
What is being tested?
The study compares two radiotherapy planning methods for treating head and neck cancer: Margin-Based and Robust planning. It aims to see which method results in better quality of life and less dry mouth after treatment.See study design
What are the potential side effects?
Potential side effects include varying degrees of dry mouth, which can affect quality of life. The specific side effects will depend on the radiotherapy planning method used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but cannot do normal activities or work.
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My cancer is a type of squamous-cell carcinoma located in the head or neck.
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I am over 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after radiotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after radiotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade of xerostomia
Xerostomia
Trial Design
2Treatment groups
Active Control
Group I: Robust Radiotherapy PlanningActive Control1 Intervention
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated to minimize the dose of radiation to normal tissue.
Group II: Margin-Based Radiotherapy PlanningActive Control1 Intervention
This arm will receive Intensity-Modulated Radiation Therapy (IMRT) that was calculated by introducing a margin to the target area.
Find a Location
Who is running the clinical trial?
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,303 Total Patients Enrolled
Mausam Patel, MDPrincipal InvestigatorUniversity of Arkansas
Gary Lewis, MDPrincipal InvestigatorUniversity of Arkansas
5 Previous Clinical Trials
80 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo standard chemotherapy.My cancer is a type of squamous-cell carcinoma located in the head or neck.I am over 21 years old.I am able to care for myself but cannot do normal activities or work.I am eligible for standard chemo-radiotherapy for head and neck cancer.I am taking medication to help produce saliva.
Research Study Groups:
This trial has the following groups:- Group 1: Robust Radiotherapy Planning
- Group 2: Margin-Based Radiotherapy Planning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for participants in the trial?
"Hosted on the clinicaltrials.gov website, this study is no longer accepting participants; it was initially posted in June 2018 and last revised a few weeks ago in early June 2022. Fortunately, there are currently 2677 other medical trials that do require volunteers to join their studies."
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