Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

Eligibility 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.
• 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.