This phase I/II tests how well accelerated brachytherapy forward chemotherapy (chemo) radiation therapy (ABC-RT) works in treating patients with stage IB3-IVA cervical cancer. ABC-RT combines internal radiation therapy (brachytherapy), which uses radioactive material placed directly into or near a tumor to kill tumor cells, followed by external beam radiation therapy (EBRT) in which high-energy beams are delivered to the tumor from outside of the body in larger doses but fewer treatments (hypofractionated). Researchers are trying to see if starting with brachytherapy will allow for effective relief of disease symptoms and to see if a hypofractionated EBRT regimen can decrease overall treatment time. Undergoing ABC-RT may be safe, tolerable and/or effective in treating patients with stage IB3-IVA cervical cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06529809.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Jessika Contreras
Phone: 314-747-7236
PRIMARY OBJECTIVES:
I. To determine the safety of ABC-RT in patients with IB3-IVA cervical cancer as measured by late toxicity.
SECONDARY OBJECTIVE:
I. To determine the preliminary efficacy of ABC-RT.
EXPLORATORY OBJECTIVES:
I. To evaluate the effect of definitive ABC-RT for locally-advanced cervical cancer on patient-reported quality of life (QOL) measures.
II. To assess the effect of definitive ABC-RT for locally advanced cervical cancer on the systemic and local immune response.
OUTLINE:
Patients undergo brachytherapy once a week (QW) for two weeks, then undergo brachytherapy QW in combination with EBRT 4 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care systemic chemotherapy as clinically indicated on study. In addition, patients undergo fludeoxyglucose-positron emission tomography (FDG-PET) during screening and follow-up. Patients may undergo magnetic resonance imaging (MRI) during screening. Patients also have the option to undergo blood sample collection on study and during follow up and/or biopsy on study.
After completion of study treatment, patients are followed up at 6 weeks and 2 months, then every 3 months for a total follow-up time of 2 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorJessika Contreras
