This phase I clinical trial studies the side effects of hypofractionated radiation therapy with adaptive planning, and to see how well it works in treating women with endometrial or cervical cancer. Many women receive radiation to the pelvis after they have undergone surgery to remove the main endometrial and/or cervical tumor. Standard radiation therapy to the pelvis is given daily (Monday-Friday) for 5-6 weeks. This can be a significant obstacle and burden for patients. Adaptive planning uses images from computed tomography (CT) or magnetic resonance imaging (MRI) to help guide the radiation beam during radiation therapy. This helps to make radiation therapy more accurate and cause less damage to healthy tissue. This can allow for radiation treatments to be delivered as fewer but larger doses, which is called hypofractionation. Giving hypofractionated radiation therapy with adaptive planning may be safe, tolerable, and/or effective in treating women with endometrial or cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06538337.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: Puja Venkat
Phone: 310-825-9775
PRIMARY OBJECTIVE:
I. Evaluate the overall acute radiation toxicity according to Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0).
SECONDARY OBJECTIVES:
I. Evaluate patient-reported quality-of-life scores using European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 (EORTC QLQ-C30) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).
II. Evaluate overall late radiation toxicity according to CTCAE v5.0.
III. Evaluate oncologic outcomes, including local control, regional control, distant metastasis control, distant metastasis-free survival, progression-free survival, and overall survival.
OUTLINE:
Patients receive hypofractionated radiation therapy over 1 hour every other day (QOD) Monday-Friday for 5 sessions in the absence of unacceptable toxicity. Patients also undergo planning CT and/or MRI prior to each radiation therapy treatment session on study.
After completion of study treatment, patients are followed up at 3 and 6 months, and then every 6 months for up to 5 years.
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorPuja Venkat