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Hypofractionated Radiochemotherapy

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment20 people
  • Recruiting US sites1
  • SponsorDenise Fabian
  • RegistryNCT06331468

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Hypofractionated Radiochemotherapy: a one-minute explainerNCT063314681 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to 120 Years
  • SexFemale
  • Healthy volunteersNo

You may be able to join if

  • 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

You cannot join if

  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Cisplatin (Drug): A total of two IV infusions of cisplatin will be administered on Day 1 and again on Day 8 +/- 1 day. Cisplatin starting dose is 40 mg/m2. Dose reduction is allowed (30 mg/m2) as needed for management of toxicities.
  • intensity modulated radiation therapy (IMRT) (Radiation): given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.
  • high-dose-rate (HDR) brachytherapy (Radiation): administered 2x weekly (allow at least 72-hours window between sessions); weekdays only for 2 weeks. The radiation dose is 7 Gy x 4 fractions.

The study

Treatment groups

Na · Single Group · masking: None

Cisplatin with concurrent Intensity Modulated Radiotherapy and Brachytherapy (Experimental)

Cisplatin two (2) one-time weekly intravenous infusions at 40 mg/m2 (70mg maximum) IMRT once daily, four fractions per week for 2 weeks 4.56 Gy x 8 fractions High dose rate Brachytherapy twice per week with a 2-day break in between sessions for a total of four brachytherapy treatments. The dose is 7 Gy x 4 fractions

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • MRI assessed rate of complete response (1 month post treatment (day 60))

Other goals

  • MRI assessed rate of complete response
  • progression-free survival (PFS)
  • overall survival (OS)
  • Treatment Completion
  • Treatment Tolerability

Planned enrollment: 20 (estimated).

Where

Recruiting US sites

  • Markey Cancer Center, Lexington, Kentucky

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 29, 2026. Public record; not medical advice.

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