Who is eligible for clinical trial NCT06080503?

Participants must meet protocol criteria for Laryngeal Carcinoma. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06080503 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-11-24

Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy (NCT06080503)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Texas Southwestern Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (9 items).

Location: University of Texas Southwestern Medical Center — Dallas, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.
1 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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Texas Southwestern Medical Center — Dallas, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗