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

NCT06529809 | Recruiting Phase 1 DMC FDA Drug FDA Device

• 2 other identifiers: 202407064R37CA287204
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Cervical Carcinoma

Keywords

Cervical cancer; Hypofractionated RT; Brachytherapy; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• Local recurrence-free survival (LRFS)

  Up to 2 year follow-up (estimated to be 2 years and 6 weeks)

• Regional recurrence-free survival (LRFS)

  Up to 2 year follow-up (estimated to be 2 years and 6 weeks)

• Progression-free survival (PFS)

  Up to 2 year follow-up (estimated to be 2 years and 6 weeks)

Study Arms (1)

Accelerated Brachytherapy Forward Chemo Radiation Therapy

EXPERIMENTAL

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.

Radiation: Hypofractionated external beam radiation; Drug: Chemotherapy; Radiation: Image-guided brachytherapy

Interventions

Chemotherapy DRUG

Concurrent chemotherapy are not dictated by the protocol and will follow standard of care guidelines

Accelerated Brachytherapy Forward Chemo Radiation Therapy

Image-guided brachytherapy RADIATION

HDR boost 7.3 Gy x 6 fractions

Accelerated Brachytherapy Forward Chemo Radiation Therapy

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)

Accelerated Brachytherapy Forward Chemo Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jessika A Contreras, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessika A Contreras, M.D.

CONTACT

314-747-7236; jcontreras@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 6 months of publication.
• Access Criteria: Data will be available for investigators whose proposed use of the data has been approved by an independent review committee.

Locations

US (1)