Short-course radiation with chemotherapy for cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives hypofractionated pelvic intensity-modulated radiation therapy (IMRT) with concurrent cisplatin, followed by high-dose-rate (HDR) brachytherapy, to women with bulky or limited-metastatic uterine cervix cancer. Key outcomes include MRI-measured tumor response at 1 and 3 months, safety and tolerability of the combined regimen, treatment completion rates, and circulating tumor cell levels before and after therapy. The trial will also report median progression-free and overall survival at one and two years. Patients undergo baseline history, physical exam, and laboratory testing within four weeks prior to enrollment and are treated at a single center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Markey Cancer Center
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Denise Fabian, MD — University of Kentucky
• Study coordinator: Yvonne Taul, RN
• Email: yvonne.taul@uky.edu
• Phone: 859-323-2354

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.