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.
Additional locations may be listed 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
