A Phase II Study of Glottic Larynx Stereotactic Ablative Radiotherapy (LT-SABR) for Early-Stage Glottic Larynx Cancer

Status: Completed
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
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• 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:

⁃ 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).

• 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.

• Patients with cognitive impairment or other limited decision making capacity with the ability to understand and willingly sign written informed consent or have the consent signed by a designated legally authorized representative (LAR)

Locations
United States
Texas
University of Texas Southwestern Medical Center
Dallas
Time Frame
Start Date: 2018-05-15
Completion Date: 2024-04-30
Participants
Target number of participants: 25
Treatments
Experimental: SBRT Treatment
Patients are all treated with stereotactic body radiation therapy (SBRT), using either CyberKnife or volumetric modulated arc therapy (VMAT). Dosing is based on the patients' assessed risk. The two cohorts are low risk and moderate risk.~Low-risk is defined by:~* Planning target volume (PTV) less than 10 cc, AND~* No reported smoking within 1 month from registration~Radiation Therapy will be delivered twice per week for 5 fractions (total 42.5 Gy)- this provides both an adequate tumoricidal dose, and a limited dose to normal tissue.~Moderate-risk is defined by:~* Planning target volume (PTV) greater than or equal to 10 cc, OR~* Smoking within 1 month from registration (no more than 1 pack per day)~Radiation Therapy will be delivered daily for 16 fraction (total 58.08 Gy)
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center

This content was sourced from clinicaltrials.gov

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