To find the highest tolerable dose of stereotactic hypofractionated radioablation (HYDRA) radiation that can be given to patients with laryngeal cancer. The safety of this radiation will also be studied.
Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx.
Stage T1N1/T2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria.
ECOG (Zubrod) performance status 0-2.
Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.
Patients who have undergone resection of primary disease.
Patients who have received induction chemotherapy for their cancer diagnosis.
Patients who have undergone a diverting tracheostomy which is either a) traversing directly through tumor, b) has been placed for true airway insufficiency. Patients with a tracheostomy placed preemptively for impending airway compromise remain eligible for enrollment.
Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer.
Single group
Stereotactic Hypofractionated Radioablation
RadiationStarting dose is 8.0 Gy per fraction for 5 fractions (total dose = 40.0 Gy). Subsequent cohorts of participants receive an additional 0.5 Gy per fraction.
Questionnaires
BehavioralQuality of life and symptom questionnaires completed at: Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.
Maximum Tolerated Dose (MTD) of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Toxicity graded using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0.
Overall Complete Response Rate of Stereotactic Hypofractionated RadioAblative (HYDRA) Treatment
Overall complete response rate with laryngeal HYDRA measured from duration of time from start of treatment to primary disease relapse.
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M.D. Anderson Cancer Center
Lead sponsor
Cancer Prevention Research Institute of Texas
Collaborator
