CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
A Phase I CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy Study for Early-stage Glottic Larynx Cancer
The feasibility of reducing fractions in early-stage laryngeal cancer has not previously
been prospectively studied, and we will therefore conduct a careful phase I bio-equivalent
dose fraction reduction study.
Patients enrolled at each dose level will undergo routine evaluations to identify potential
toxicities as well functional voice analyses. Adequate waiting periods will be used to
ensure that fraction reduction does not proceed prior to observing toxicity. 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.
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.
188.8.131.52 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
β-HCG or negative serum quantitative β-HCG or within 2 weeks prior to registration for
women of childbearing potential
3.2.1 Evidence of fixed vocal cord (Stage cT3) 3.2.2 Evidence of thyroid or soft tissue
invasion (Stage cT4) 3.2.3 Evidence of positive nodal disease (Stage N1) 3.2.4 Evidence of
metastatic disease (Stage M1) 3.2.5 Subjects may not be receiving any other
investigational agents. 3.2.6 Non-squamous histology including lymphoma, neuroendocrine
carcinoma, adenocarcinoma, or other histology.
3.2.7 Previous laryngeal surgery or laser therapy 3.2.8 Previous head and neck radiation
therapy involving the glottic larynx 3.2.9 Previous head and neck malignancy other than
superficial basal cell or squamous cell carcinoma 3.2.10 Patients with collagen vascular
disease, specifically dermatomyositis with a CPK level above normal or active skin rash,
systemic lupus erythematosis, or scleroderma.
3.2.11 Any prior treatment with radiation therapy or chemotherapy for the currently
diagnosed larynx cancer prior to registration.
3.2.12 History of another uncontrolled malignancy other than superficial basal cell
carcinoma or squamous cell carcinoma of skin diagnosed within the past 3 years 3.2.13
Subjects must not be pregnant due to the potential for congenital abnormalities.
3.2.14 Patients smoking in excess of 2 packs of cigarettes per day. 3.2.15 ECOG
performance status ≥ 2 3.2.16 Life expectancy < 3 years