ABC-RT for Locally-advanced Cervical Cancer

This study is testing a new way to deliver radiation therapy for locally advanced cervical cancer. Standard treatment usually involves chemotherapy and radiation over many daily sessions. This study aims to see if combining upfront image-guided brachytherapy (a type of internal radiation) with hypofractionated external beam radiation (fewer, higher-dose radiation treatments) can be effective and reduce side effects. You may be able to join if you are a woman, at least 18 years old, and have newly diagnosed cervical cancer (FIGO 2018 clinical stage IB3-IVA) that your doctor believes can be treated with radiation. The main goal is to see how many participants experience severe gastrointestinal or urinary side effects within two years and six weeks after treatment. The current status of this study is unclear.

Study design
This is a feasibility study involving 50 participants. It is testing a specific radiation treatment approach without comparing it directly to another treatment group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for late gastrointestinal and urinary side effects for up to two years and six weeks after treatment.

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NCT06529809

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Washington University School of Medicine
~50 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Hypofractionated external beam radiationChemotherapyImage-guided brachytherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant
Measured over Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks)
Locally Advanced Cervical Carcinoma
1 sites across 1 states
Missouri1
  • Stephanie Markovina, M.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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.

Exclusion

Any prior pelvic radiotherapy.
Any prior gynecologic or other pelvic malignancy.
Any prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for the trial.
Evidence of metastatic disease outside of the pelvis or para-aortic nodes.
Previous hysterectomy or planned hysterectomy as part of initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy.
Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation.
Major surgery ≤ 3 weeks prior to initiating protocol therapy; if a patient has had major surgery prior to 3 weeks, they must have recovered from any surgical effects.
Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.
  • Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participantBetween day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks)

    -Must be at least possibly related to RT.