A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer

Study ID
STU 062013-052

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Susan Cooley
214-633-1754
susan.cooley@utsouthwestern.edu

Principal Investigator
Baran Sumer

Summary

The purpose of the study will be either to determine the maximal fraction reduction possible until a dose is reached where a dose-limiting toxicity occurs. The initial dose and fractionation will be 50 Gy in 15 fractions with the goal to reduce number of fractions to a dose of 42.5 Gy in 5 fractions. The rationale for using 5 fractions is that it is tolerated in centrally located lung tumors at a dose of 50 Gy in 5 fractions, and thus, is likely to be tolerated in large calliber airways.

We hypothesize that the larynx has a similar radiation toxicity profile as the central lung airways and can be treated safely using 5 fractions. Potential dose limiting toxicity from this treatment will likely relate to voice hoarseness, stridor, or cough. Strict dosimetric guidelines to reduce the probability of toxicity will be used according to our institutional dosimetric analyses of CyberKnife larynx irradiation of anthropomorphic phantoms.

Participant Eligibility

3.1.1 Stage Tis, T1, or T2 laryngeal squamous cancer as defined by American Joint Commission on Cancer (AJCC) 2007 staging system
3.1.2 Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
3.1.3 Direct laryngoscopy showing no evidence of greater than Stage II true glottic larynx cancer
3.1.4 Chest X-ray or CT-scan showing no evidence of metastatic disease
3.1.5 CT-scan of the neck showing no evidence of nodal involvement
3.1.6 Age >= 18 years.
3.1.7 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.
3.1.6.1 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).
3.1.8 Ability to understand and the willingness to sign a written informed consent
3.1.9 Eastern Cooperative Oncology Group (ECOG) performance status 0-1
3.1.10 Negative Urine [BETA]-HCG or negative serum quantitative [BETA]-HCG or within 2 weeks prior to registration for women of childbearing potential