Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. An important component to treatment efficacy is overall treatment time. Prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required. This is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed biopsy proven FIGO (2018) clinical stage IB3-IVA cervical carcinoma.

• Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix

• Candidate for definitive radiation therapy as determined by treating radiation oncologist.

• At least 18 years of age.

• ECOG performance status ≤ 2

• Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representative may sign and give informed consent on behalf of study participants.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Jessika A Contreras, M.D.
jcontreras@wustl.edu
314-747-7236
Time Frame
Start Date: 2025-02-11
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Accelerated Brachytherapy Forward Chemo Radiation Therapy
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) combines hypofractionated external beam radiation therapy (EBRT) with concurrent chemotherapy and early upfront, image-guided brachytherapy. In this study, patients start with 2 fractions of brachytherapy prior to initiation of EBRT-based chemoradiotherapy. Total time from treatment planning is approximately 36-42 days.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov