RecruitingPhase 1NCT03114462

Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer

A Phase I Trial of Stereotactic HYpofractionateD RadioAblative (HYDRA) Treatment of Laryngeal Cancer


Sponsor

M.D. Anderson Cancer Center

Enrollment

11 participants

Start Date

Aug 9, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a type of precise, high-dose radiation treatment (called HYDRA — stereotactic hypofractionated radioablative therapy) for laryngeal (voice box) cancer, to see if it can be as effective as standard radiation while preserving the voice box and reducing treatment time. **You may be eligible if...** - You are older than 18 - You have been diagnosed with squamous cell carcinoma of the larynx (voice box cancer), confirmed by biopsy - Your cancer is at a specific stage (T1N1, T2, T3, or T4a, with limited lymph node involvement) - Your overall health is good enough for normal daily activities (ECOG 0-2) - A doctor has assessed you as physically eligible for partial larynx surgery (an evaluation checklist is used) - You are able to understand English and sign an informed consent form - If you can become pregnant, you agree to use effective contraception during and for 90 days after treatment **You may NOT be eligible if...** - You have already had surgery to remove the primary tumor - You have previously received radiation to the head and neck area - You have another active cancer - You are pregnant or currently breastfeeding - You cannot understand English or provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT03114462


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