RecruitingNot Applicable

Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy

United States67 participantsStarted 2024-03-14

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.

To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.

Timeframe: 3 months following treatment

NCT IDNCT06080503

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-11-01

David J Sher, MD,MPH

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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:
✓. 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.