Hypofractionated Radiochemotherapy for Uterine Cervix Cancer

This study is testing a new way to treat uterine cervix cancer using a combination of chemotherapy and radiation. You would receive cisplatin (a chemotherapy drug) through an IV twice, along with two types of radiation: intensity modulated radiation therapy (IMRT) given four times a week for two weeks, and high-dose-rate (HDR) brachytherapy given twice a week for two weeks. The goal is to see how well this treatment shrinks tumors, how safe it is, and how long people live without their cancer growing. This study is for women aged 18 to 120 with certain types of untreated, bulky, or metastatic uterine cervix cancer. Researchers plan to enroll 20 participants. The main way they'll measure success is by looking at MRI scans to see if the cancer has completely responded to treatment one month after it finishes. The current status of this study is unclear.

Study design: This is an interventional study with a planned enrollment of 20 participants. It is designed to investigate the effects of a specific treatment combination.
What's involved: You would receive two IV infusions of cisplatin, IMRT radiation four times a week for two weeks, and HDR brachytherapy twice a week for two weeks. Your response to treatment will be assessed with an MRI one month after treatment ends (around day 60).
Compensation: Not stated in the trial record.
Follow-up: Your response to treatment will be assessed at 1 month and 3 months post-treatment. Progression-free survival and overall survival will be evaluated at 1 and 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Hypofractionated Radiochemotherapy

Recruiting

PHASE2Ages 18+InterventionalTreatment

Denise Fabian

~20 participants

Updated 2026-07-30 on ClinicalTrials.gov

What's tested:Cisplatinintensity modulated radiation therapy (IMRT)high-dose-rate (HDR) brachytherapy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

MRI assessed rate of complete response

Measured over 1 month post treatment (day 60)

Conditions

Uterine Cervix Cancer

Where it's being run

1 sites across 1 states

Kentucky1

Study leadership

Denise Fabian, MD · PRINCIPAL_INVESTIGATOR · University of Kentucky

Who to contact

Yvonne Taul, RN

[email protected]

859-323-2354

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Untreated, pathologically or cytologically-confirmed diagnosis of FIGO Stage IB3, II, or IIIA-IIIC1 bulky ( ≥ 6cm) or Stage IVA or Stage IVB (FIGO 2018) squamous, adenosquamous, or adenocarcinoma of the uterine cervix with limited metastatic burden (not requiring urgent systemic therapy).

Adequate organ and marrow function

Gynecologic Oncology Group performance status of 0, 1, or 2

Patient agrees to use two forms of birth control if they are of child-bearing potential

Ability to understand and the willingness to sign a written informed consent document

Exclusion

Presence of another concurrent active invasive malignancy

Prior invasive malignancy diagnosed within the last three years, with the following two exceptions: \[a\] non-melanoma skin cancer and/or \[b\] prior in situ carcinoma of the cervix

Receipt of prior pelvic radiotherapy for any reason that would contribute radiation dose that would exceed tolerance of normal tissues, at the discretion of the treating physician

Currently receiving any other investigational agent(s) for the treatment of cancer

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cisplatin or other agents used in study

Presence of uncontrolled intercurrent illness as determined by the treating physician

pregnant or lactating

Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better

What this trial measures

MRI assessed rate of complete response1 month post treatment (day 60)
MRI-assessed rates of complete response as estimated by the number of CRs (complete response per RECIST v1.1) divided by the total number of evaluable subjects

Trialytics