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

Phase 1

Recruiting

• Conditions: Locally Advanced Cervical Carcinoma
• Interventions: Radiation: Hypofractionated external beam radiation; Drug: Chemotherapy; Radiation: Image-guided brachytherapy

• Registration Number: NCT06529809
• Lead Sponsor: Washington University School of Medicine

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 l...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-31
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated Brachytherapy Forward Chemo Radiation Therapy	Chemotherapy	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.
Accelerated Brachytherapy Forward Chemo Radiation Therapy	Hypofractionated external beam radiation	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.
Accelerated Brachytherapy Forward Chemo Radiation Therapy	Image-guided brachytherapy	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 Measures

Name	Time	Method
Late treatment related grade 3 or greater gastrointestinal and genitourinary adverse events experienced by participant	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)	-Must be at least possibly related to RT.
Progression-free survival (PFS)	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)

Secondary Outcome Measures

Name	Time	Method
Regional control	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)
Local control	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States