CompletedNot Applicable

Stereotactic Ablative Radiotherapy for Early-stage Glottic Larynx Cancer

United States25 participantsStarted 2018-05-15

Plain-language summary

This is a prospective study to determine the local control and quality-of-life outcomes of using SBRT for early-stage glottic larynx cancer.

Age range18 Years – 120 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 I-II (American Joint Committee on Cancer AJCC, 7th 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.
✓. Age ≥ 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:
✓. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
✓. 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.

Number of Patients With Local Failure Following SABR Treatment of Early Glottic Larynx Cancers

Timeframe: 2 years

NCT IDNCT03548285

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-25

Results submitted2024-09-23

Who can participate

Age range18 Years – 120 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 I-II (American Joint Committee on Cancer AJCC, 7th 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.
✓. Age ≥ 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:
✓. Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential.
✓. 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.