A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer
M.D. Anderson Cancer Center
Summary
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.
Description
Study Groups: If participant is found to be eligible to take part in this study, participant will be assigned to a radiation level of HYDRA radiation based on when participant joins this study. Up to 5 dose levels of HYDRA radiation will be tested. Up to 10 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of HYDRA radiation is found. HYDRA Radiation Administration:…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients older than 18 years of age with histologically proven squamous cell carcinoma of the larynx. 2. Stage T1N1/T2-4aN0-1 disease, as defined by American Joint Committee on Cancer (AJCC) criteria. 3. ECOG (Zubrod) performance status 0-2. 4. 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. 5. Women of child-bearing potential and men must agree to use adequate contraception (hormon…
Interventions
- RadiationStereotactic Hypofractionated Radioablation
Starting 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.
- BehavioralQuestionnaires
Quality 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.
Location
- MD Anderson Cancer CenterHouston, Texas