Short-course radiation with chemotherapy for cervical cancer
Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer
This trial will test whether a shorter, higher-dose pelvic radiation schedule given with cisplatin and followed by brachytherapy helps women with bulky or limited-metastatic cervical cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | Female |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06331468 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with untreated FIGO 2018 stage IB3, II, IIIA-IIIC1 bulky (≥6 cm) or stage IVA/IVB cervical squamous, adenosquamous, or adenocarcinoma with limited metastatic burden, GOG performance status 0–2, and adequate organ and marrow function who agree to required contraception and consent procedures.
Not a fit: Patients with widespread metastatic disease requiring immediate systemic therapy, prior pelvic radiation that would exceed normal tissue tolerances, another active invasive cancer, or poor performance status are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could shorten the overall treatment time while providing effective local control and reducing the burden of care for patients with bulky or limited-metastatic cervical cancer.
How similar studies have performed: Concurrent cisplatin with conventional fractionation is a standard approach, but using hypofractionated pelvic radiation with concurrent cisplatin is relatively novel in this setting and has only limited data from smaller or palliative series.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lexington, Kentucky
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.