Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
NCT ID: NCT06529809
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2025-02-11
2031-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jessika A Contreras, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Jessika A Contreras, M.D.
Role: primary
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202407064
Identifier Type: -
Identifier Source: org_study_id