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Clinical Trial NCT06529809 for Locally Advanced Cervical Carcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Washington University School of MedicineAccelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer Phase 1, Phase 2 50 Overall Survival
Clinical Trial NCT06529809 is designed to study Treatment for Locally Advanced Cervical Carcinoma. It is a Phase 1 Phase 2 interventional study that is recruiting, having started on 11 February 2025, with plans to enroll 50 participants. Led by Washington University School of Medicine, it is expected to complete by 31 December 2031. The latest data from ClinicalTrials.gov was last updated on 24 December 2025.
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, strat...Show More
Official Title
Accelerated Brachytherapy Forward Chemo Radiation Therapy (ABC-RT) for Locally-advanced Cervical Cancer
Conditions
Locally Advanced Cervical CarcinomaOther Study IDs
NCT ID Number
Start Date (Actual)
2025-02-11
Last Update Posted
2025-12-24
Completion Date (Estimated)
2031-12-31
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
Phase 1
Phase 2
Phase 2
Status
Recruiting
Keywords
Cervical cancer
Hypofractionated RT
Brachytherapy
Pembrolizumab
Hypofractionated RT
Brachytherapy
Pembrolizumab
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAccelerated 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant | -Must be at least possibly related to RT. | Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Local recurrence-free survival (LRFS) | A local recurrence is defined as histologic or radiographic evidence of cancer in the cervix. Local recurrence-free survival is defined as the duration of time from the start of treatment to the time of local recurrence or death, whichever occurs first. The living patients with CR, PR, or SD in the cervix are censored at the corresponding date. | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) |
Regional recurrence-free survival (LRFS) | A regional recurrence is defined as histologic or radiographic evidence of cancer in the pelvic or para-aortic nodes. Regional recurrence-free survival is defined as the duration of time from the start of treatment to the time of regional recurrence or death, whichever occurs first. The living patients with CR, PR, or SD in the pelvis or para-aortic lymph nodes are censored at the corresponding date. | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) |
Progression-free survival (PFS) | Progression- free survival is defined as the duration of time from the start of treatment to progression or death, whichever occurs first. The living patients without progression are censored at the last follow-up. | Up to 2 year follow-up (estimated to be 2 years and 6 weeks) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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.
- 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.
Washington University School of Medicine462 active studies to exploreNational Cancer Institute (NCI)3019 active studies to exploreStudy Central Contact
Contact: Jessika A Contreras, M.D., 314-747-7236, [email protected]
1 Study Locations in 1 Countries
Missouri
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Jessika A Contreras, M.D., Contact, 314-747-7236, [email protected]
Jessika A Contreras, M.D., Principal Investigator
Stephanie Markovina, M.D., Ph.D., Sub-Investigator
David Lakomy, M.D., Sub-Investigator
Julie K Schwarz, M.D., Ph.D., Sub-Investigator
Shawn Wu, M.S., Sub-Investigator
Dineo Khabele, M.D., Sub-Investigator
Matthew A Powell, M.D., Sub-Investigator
Premal H Thaker, M.D., M.S., Sub-Investigator
Carolyn McCourt, M.D., Sub-Investigator
Andrea Hagemann, M.D., MSCI, Sub-Investigator
L. Stewart Massad, Jr., M.D., Sub-Investigator
Brooke E Sanders, M.D., Sub-Investigator
Lindsay Kuroki, M.D., MSCI, Sub-Investigator
Eric Laugeman, M.S., Sub-Investigator
Esther Lu, Ph.D., Sub-Investigator
Recruiting