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Radiation Planning

Robust vs. Margin-Based Radiotherapy for Head and Neck Cancer

N/A
Waitlist Available
Led By Gary Lewis, 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)
Must not have
Unable to receive standard chemotherapy
Use of saliva stimulating prescription drugs such as Evoxac or Salagen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after radiotherapy
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two radiotherapy planning methods in head and neck cancer patients to see which one causes fewer side effects like dry mouth. The results will help design future studies.

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot undergo standard chemotherapy.
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I am taking medication to help produce saliva.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after radiotherapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after radiotherapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade of xerostomia
Xerostomia

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
494 Previous Clinical Trials
150,280 Total Patients Enrolled
Gary Lewis, MDPrincipal InvestigatorUniversity of Arkansas
5 Previous Clinical Trials
80 Total Patients Enrolled
Mausam Patel, MDPrincipal InvestigatorUniversity of Arkansas

Media Library

Margin-Based Radiotherapy planning (Radiation Planning) Clinical Trial Eligibility Overview. Trial Name: NCT03552965 — N/A
Squamous Cell Carcinoma Research Study Groups: Robust Radiotherapy Planning, Margin-Based Radiotherapy Planning
Squamous Cell Carcinoma Clinical Trial 2023: Margin-Based Radiotherapy planning Highlights & Side Effects. Trial Name: NCT03552965 — N/A
Margin-Based Radiotherapy planning (Radiation Planning) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03552965 — N/A
~4 spots leftby Jul 2025
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