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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT06529809
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Cervical Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hypofractionated external beam radiation — 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 — DRUG
    Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines
  • Image-guided brachytherapy — RADIATION
    HDR boost 7.3 Gy x 6 fractions

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2031
Completion
Dec 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Jessika A Contreras, M.D.
[email protected]
314-747-7236
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)

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