RecruitingNot ApplicableNCT06080503

Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

G-FORCE: Phase II Randomized Study of Glottic Larynx Hypofractionated Radiotherapy Versus ConvEntional Radiotherapy

Sponsor

University of Texas Southwestern Medical Center

Enrollment

67 participants

Start Date

Mar 14, 2024

Study Type

INTERVENTIONAL

Conditions

To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.

Min Age: 18 Years

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.
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.
Minimum age is 18 years.
ECOG Performance Status 0-2
Women of child-bearing potential and men must agree to 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Ability to understand and the willingness to sign a written informed consent.

AJCC stage III or stage IV larynx cancer
Involvement of the arytenoid cartilage beyond the vocal process.
Prior chemotherapy for treatment of the targeted larynx lesion.
Synchronous primaries in the head and neck
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
Subjects smoking in excess of 1 pack of cigarettes per day.
Subjects may not be receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.