Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
FEMALE
NCT06529809

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

Led by Washington University School of Medicine · Updated on 2025-12-24

50

Participants Needed

1

Research Sites

359 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 64 2
  • Ability to understand and willing to sign an IRB approved written informed consent document, or legally authorized representative can consent
Not Eligible

You will not qualify if you...

  • Any prior pelvic radiotherapy
  • Any prior gynecologic or other pelvic malignancy
  • Any prior or concurrent malignancy that may interfere with safety or efficacy assessment of investigational regimen
  • Evidence of metastatic disease outside pelvis or para-aortic nodes
  • Previous or planned hysterectomy as part of cervical cancer therapy, including prior supracervical hysterectomy
  • Pregnant and/or breastfeeding; women of childbearing potential must have negative pregnancy test within 7 days prior to simulation
  • Major surgery within 3 weeks prior to starting treatment, or not recovered from surgery effects if surgery was earlier
  • Serious uncontrolled medical disorder, systemic disease, or active uncontrolled infection such as uncontrolled arrhythmia, recent myocardial infarction, uncontrolled COPD, major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

J

Jessika A Contreras, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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