This phase II trial compares the effect of the toxicities patients experience with hypofractionated radiation versus the standard method of giving radiation therapy to patients with stage 0-II glottic (vocal cord) larynx squamous cell cancer. Radiation therapy is well established and a recommended treatment for treatment of early glottic larynx cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Hypofractionated radiation therapy is useful because it treats a much smaller target using highly-precise technology. The treatment can therefore be delivered over fewer doses, with a higher dose each day. This smaller target means that a lower volume of normal tissue is irradiated (treated with radiation), which may lead to fewer short- and long-term toxicities. Giving hypofractionated radiation therapy may reduce toxicity outcomes and be an effective treatment option in patients with stage 0-II glottic larynx squamous cell cancer compared to the standard method.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06080503.
Locations matching your search criteria
United States
Texas
Dallas
UT Southwestern/Simmons Cancer Center-DallasStatus: Active
Contact: David Jonathan Sher
Phone: 214-645-7607
PRIMARY OBJECTIVE:
I. To compare the acute toxicity outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.
SECONDARY OBJECTIVES:
I. To compare the 3 and 12-month patient-reported voice outcomes between patients treated with highly-conformal hypofractionated radiotherapy and conventional radiotherapy.
II. To compare the local control rates at 12 months following treatment
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients with low-risk disease undergo glottic larynx-stereotactic ablative radiotherapy (LT-SABR) twice a week (BIW) for 5 treatments over 3-5 weeks in the absence of disease progression or unacceptable toxicity. Patients with moderate-risk disease undergo LT-SABR once a week (QW) for 5 treatments over 3-5 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo positron emission tomography (PET)/computed tomography (CT) or CT during screening and follow-up.
ARM B: Patients undergo conventional radiation therapy (RT) for 28 or 29 treatments once a day (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT or CT during screening and follow-up.
After completion of study treatment, patients are followed up at 2 weeks, 3 months, and 12 months.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorDavid Jonathan Sher
