This clinical trial compares the effect of 3 fraction high dose rate (HDR) brachytherapy to standard 4 fraction HDR brachytherapy in treating patients with cervical cancer that has spread to nearby tissue of lymph nodes (locally advanced). Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. The goal of brachytherapy is to deliver high doses of radiation to the tumor region with minimum damage to the surrounding tissue. Standard HDR brachytherapy consists of 4 fractions and each brachytherapy procedure can cause discomfort, anxiety and distress to the patient. Giving 3 fraction HDR brachytherapy may reduce anxiety and distress and may be as effective as the standard 4 fraction HDR brachytherapy in treating patients with locally advanced cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07022470.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Active
Contact: Elizabeth A. Kidd
Phone: 650-725-2174
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of 3 fraction brachytherapy compared to a standard 4 fraction brachytherapy regimen in patients with locally advanced cervical cancer.
SECONDARY OBJECTIVES:
I. To determine clinical factors predictive of the feasibility of a 3 fraction brachytherapy regimen.
II. To assess the impact of 3 fraction versus 4 fraction brachytherapy regimen on patient-reported outcomes including quality of life, distress, and financial burden.
III. To compare resource utilization by the patient and healthcare system between 3 fraction versus 4 fraction brachytherapy regimen.
IV. To evaluate the benefits of static and dynamic pre-planning on the dosimetry at the time of the first brachytherapy session.
V. To evaluate the safety of the 3 fraction regimen in comparison to a standard 4 fraction regimen by examining the rates of grade 3 (G3)+ gastrointestinal (GI) and genitourinary (GU) toxicity.
OUTLINE: Patients able to achieve high risk clinical target volume maximum dose to 90% of volume > 85 Gy and organ at risk constraints are assigned to Arm I. Patients unable to met constraints or steps on the first implant and fraction are assigned to Arm II.
ARM I: Patients undergo standard HDR brachytherapy for up to 3 fractions in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo standard HDR brachytherapy for up to 4 fractions in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 2 weeks and 3-5.5 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorElizabeth A. Kidd
