G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy
University of Texas Southwestern Medical Center
Summary
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Description
Screening/Baseline Procedures Assessments performed exclusively to determine eligibility for this study will be done only after obtaining informed consent. Assessments performed for clinical indications (not exclusively to determine study eligibility) may be used for baseline values even if the studies were done before informed consent was obtained. All screening procedures must be performed within 30 days prior to registration into the study unless otherwise stated. The screening procedures include: Informed Consent Medical history--Complete medical and surgical history Demographics--Age, g…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx. 2. Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease. 3. Minimum age is 18 years. 4. ECOG Performance Status 0-2 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier…
Interventions
- RadiationLT-SABR
42.5 Gy in 5 fractions Low-risk: twice/week Moderate-risk: weekly
- RadiationIMRT
63 Gy in 28 fractions (T1) 65.25 Gy in 29 fractions (T2)
Location
- University of Texas Southwestern Medical CenterDallas, Texas