Intensity-modulated Radiation Therapy (IMRT) for Oral Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oral Squamous Cell Carcinoma+6 More
Intensity-modulated Radiation Therapy (IMRT) - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to give radiation therapy that may be better than the current standard.

Eligible Conditions
  • Oral Squamous Cell Carcinoma
  • Hypopharyngeal Squamous Cell Carcinoma
  • Laryngeal Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 12-24 months

1-24 months
Feeding tube dependence
General patient-reported quality of life
Head and neck patient-reported quality of life
Swallowing-related patient-reported quality of life
Xerostomia-related patient-reported quality of life
1-3 months
Clinician-reported acute toxicities
12 months
Phase 2: Swallowing-related patient-reported quality of life
12-24 months
Locoregional control
Progression free survival
3 months
Phase 1: Maximally tolerated dose of hypofractionated radiation therapy
6-24 months
Clinician-reported late toxicities

Trial Safety

Trial Design

2 Treatment Groups

Conventionally fractionated radiotherapy
1 of 2
Hypofractionated radiotherapy
1 of 2

Active Control

Experimental Treatment

98 Total Participants · 2 Treatment Groups

Primary Treatment: Intensity-modulated Radiation Therapy (IMRT) · No Placebo Group · Phase 1 & 2

Hypofractionated radiotherapy
Radiation
Experimental Group · 1 Intervention: Intensity-modulated Radiation Therapy (IMRT) · Intervention Types: Radiation
Conventionally fractionated radiotherapy
Radiation
ActiveComparator Group · 1 Intervention: Intensity-modulated Radiation Therapy (IMRT) · Intervention Types: Radiation

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-24 months

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
943 Previous Clinical Trials
606,084 Total Patients Enrolled
Dominic Moon, MDPrincipal Investigator - UT Southwestern Medical Center
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
24 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are of child-bearing potential and you must use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
You are using hormonal contraceptives or barrier methods with a spermicide.
A woman who becomes pregnant or suspects she is pregnant while participating in this study should inform her treating physician immediately.
You are of childbearing potential.
Inclusion criteria will be the same for Phase I and Phase II.
The final patient margin must be <5 mm without disease on ink or initial positive margin in the specimen regardless of the final patient margin (e.g.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 31st, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.