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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-26
• Study First Posted: 2024-07-31
• Study Start: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• 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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	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	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	Between day 91 and 2 year follow-up (estimated to be 2 years and 6 weeks)	-Must be at least possibly related to RT.

Secondary Outcome Measures

Name	Time	Method
Local recurrence-free survival (LRFS)	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)	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.
Regional recurrence-free survival (LRFS)	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)	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.
Progression-free survival (PFS)	Up to 2 year follow-up (estimated to be 2 years and 6 weeks)	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.

Trial Locations

Locations (1)

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