Status:
RECRUITING
Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Laryngeal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Detailed 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 indicatio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 14 2029
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT06080503
Start Date
March 14 2024
End Date
March 14 2029
Last Update
November 26 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390