NCT06080503 Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy
| NCT ID | NCT06080503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Laryngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 67 participants |
| Start Date | 2024-03-14 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 67 participants in total. It began in 2024-03-14 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Eligibility Criteria
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 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. 5.1 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). 6. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. AJCC stage III or stage IV larynx cancer 2. Involvement of the arytenoid cartilage beyond the vocal process. 3. Prior chemotherapy for treatment of the targeted larynx lesion. 4. Synchronous primaries in the head and neck 5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields. 6. Subjects smoking in excess of 1 pack of cigarettes per day. 7. Subjects may not be receiving any other investigational agents. 8. 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.
Contact & Investigator
David Sher, MD, MPH
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06080503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Laryngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06080503 currently recruiting?
Yes, NCT06080503 is actively recruiting participants. Contact the research team at David.Sher@UTSouthwestern.edu for enrollment information.
Where is the NCT06080503 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06080503 clinical trial?
NCT06080503 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is David Sher, MD, MPH at University of Texas Southwestern Medical Center. The trial plans to enroll 67 participants.