NCT06529809 Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
| NCT ID | NCT06529809 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Washington University School of Medicine |
| Condition | Locally Advanced Cervical Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-02-11 with a primary completion date of 2031-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jessika A Contreras, M.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06529809 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Locally Advanced Cervical Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06529809 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06529809 currently recruiting?
Yes, NCT06529809 is actively recruiting participants. Contact the research team at jcontreras@wustl.edu for enrollment information.
Where is the NCT06529809 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT06529809 clinical trial?
NCT06529809 is sponsored by Washington University School of Medicine. The principal investigator is Jessika A Contreras, M.D. at Washington University School of Medicine. The trial plans to enroll 50 participants.