Recruiting
Phase 1
Phase 2

Brachytherapy & Radiation

Sponsor:

Washington University School of Medicine

Code:

NCT06529809

Conditions

Locally Advanced Cervical Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypofractionated external beam radiation

Chemotherapy

Image-guided brachytherapy

Study Details

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.

Conditions

Locally Advanced Cervical Carcinoma

Study ID

NCT06529809

Start date

Feb 11, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Accelerated Brachytherapy Forward Chemo Radiation Therapy

Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) combines hypofractionated external beam radiation therapy (EBRT) with concurrent chemotherapy and early upfront, image-guided brachytherapy. In this study, patients start with 2 fractions of brachytherapy prior to initiation of EBRT-based chemoradiotherapy. Total time from treatment planning is approximately 36-42 days.

Interventions

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)

Chemotherapy

Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines

Image-guided brachytherapy

HDR boost 7.3 Gy x 6 fractions

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Stephanie Markovina, M.D.

314-747-1786smarkovina@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Stephanie Markovina, M.D.

314-747-1786smarkovina@wustl.edu

Principal Investigator:

Stephanie Markovina, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Cervical cancer
  • Hypofractionated RT
  • Brachytherapy
  • Pembrolizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-07-27.