NCT06529809 · Washington University School of Medicine
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
What this study is about
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 effectiveness is overall treatment time.
View original scientific description
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.
Interventions
RADIATION
Hypofractionated external beam radiation
Central pelvis (19.05 Gy in 15 fractions), nodal basins (40 Gy in 15 fractions), with a simultaneous integrated boost to grossly positive lymph nodes (48 Gy in 15 fractions)
DRUG
Chemotherapy
Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines
RADIATION
Image-guided brachytherapy
HDR boost 7.3 Gy x 6 fractions
Primary outcome measures
Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant
Time frame: Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks)
-Must be at least possibly related to RT.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- St Louis, Missouri
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 24, 2025 · Source of record for eligibility and locations