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NCT Number: NCT06529809

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Andrea Hagemann, M.D., MSCI

SUB_INVESTIGATOR

Brooke E Sanders, M.D.

SUB_INVESTIGATOR

Carolyn McCourt, M.D.

SUB_INVESTIGATOR

David Lakomy, M.D.

SUB_INVESTIGATOR

Dineo Khabele, M.D.

SUB_INVESTIGATOR

Eric Laugeman, M.S.

SUB_INVESTIGATOR

Esther Lu, Ph.D.

SUB_INVESTIGATOR

Julie K Schwarz, M.D., Ph.D.

SUB_INVESTIGATOR

L. Stewart Massad, Jr., M.D.

SUB_INVESTIGATOR

Lindsay Kuroki, M.D., MSCI

SUB_INVESTIGATOR

Matthew A Powell, M.D.

SUB_INVESTIGATOR

Premal H Thaker, M.D., M.S.

SUB_INVESTIGATOR

Shawn Wu, M.S.

SUB_INVESTIGATOR

Stephanie Markovina, M.D.

CONTACT

[email protected]

314-747-1786

Stephanie Markovina, M.D., Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

    -Must be at least possibly related to RT.

Secondary outcomes

  1. Local recurrence-free survival (LRFS)

    Time frame: 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.

  2. Regional recurrence-free survival (LRFS)

    Time frame: 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.

  3. Progression-free survival (PFS)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Markovina, M.D.

CONTACT

[email protected]

314-747-1786

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jul 31, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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