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NCT06529809RecruitingPhase 1/2

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

Source: ClinicalTrials.gov · Last updated 27 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
26 Jul 2024
Start date
11 Feb 2025
Primary completion date
31 Dec 2031
Lead sponsor
Washington University School of Medicine
NCT number
NCT06529809

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 50
  • From 11 Feb 2025 to the primary completion date, 31 Dec 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Evidence of metastatic disease outside of the pelvis or para-aortic nodes.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.