Actively Recruiting
Accelerated Brachytherapy Forward Chemo Radiation Therapy for Locally Advanced Cervical Cancer
Led by Washington University School of Medicine · Updated on 2025-12-24
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach called Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for women with locally advanced cervical cancer (FIGO 2018 stage IB3-IVA). The study aims to determine how this treatment affects late gastrointestinal and urinary side effects, cancer control including recurrence-free survival, and immune system responses. This approach is important because longer overall treatment times have been linked to worse outcomes in cervical cancer, so delivering radiation efficiently is key. The treatment combines hypofractionated external beam radiation therapy (EBRT) with concurrent chemotherapy and an early upfront, image-guided brachytherapy boost. Patients start with two fractions of brachytherapy before beginning EBRT-based chemoradiotherapy. Radiation is delivered to the central pelvis, lymph nodes, and grossly positive nodes with specific doses in 15 fractions, alongside six fractions of high-dose-rate brachytherapy. The total treatment duration from planning is approximately 36 to 42 days. Participants will be closely monitored through regular follow-up visits for up to two years and six weeks after treatment. Researchers will assess late severe gastrointestinal and urinary side effects, as well as cancer recurrence locally, regionally, and overall progression-free survival. The study also tracks immune responses and treatment tolerance. This detailed monitoring helps evaluate both safety and cancer control over the longer term for women receiving this accelerated therapy.
CONDITIONS
Brief Title
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed biopsy-proven cervical carcinoma stage IB3-IVA by FIGO 2018 criteria
- Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
- Candidate for definitive radiation therapy as determined by treating radiation oncologist
- At least 18 years old
- ECOG performance status 2 or less
- Ability to understand and willing to sign informed consent or have a legal representative sign
You will not qualify if you...
- Prior pelvic radiotherapy
- Prior gynecologic or other pelvic malignancy
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Evidence of metastatic disease outside pelvis or para-aortic nodes
- Previous or planned hysterectomy as part of initial cervical cancer therapy
- Pregnant or breastfeeding; negative pregnancy test required before simulation
- Major surgery within 3 weeks before starting protocol therapy without full recovery
- Serious uncontrolled medical disorder, nonmalignant systemic disease, or active uncontrolled infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 6 weeks
Participants receive accelerated brachytherapy forward chemo radiation therapy, which includes hypofractionated external beam radiation, concurrent chemotherapy following standard care, and image-guided brachytherapy. Treatment planning and delivery take approximately 36 to 42 days.
Multiple visits during treatment for radiation and chemotherapy sessions
Duration - Up to 2 years and 6 weeks
Participants are monitored for late treatment-related adverse events and disease recurrence after treatment completion.
Regular follow-up visits during this period
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
J
Jessika A Contreras, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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