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NCT06331468 · ClinicalTrials.gov registry record · Phase 2
Hypofractionated Radiochemotherapy
A Phase 2 study of Uterine Cervix Cancer, sponsored by Denise Fabian.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06331468 is a Phase 2 study of Uterine Cervix Cancer that is actively recruiting participants, run by Denise Fabian. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06331468, a Phase 2 study of Uterine Cervix Cancer, is actively recruiting participants, sponsored by Denise Fabian.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are: * What is the MRI-assessed rate of response at 1-month and 3-months post-treatment? * What is the safety and tolerability of cisplatin-based hypofractionated pelvic Intensity Modulated Radiation Therapy (IMRT) followed by brachytherapy? * What is the median progression-free survival and overall survival at 1 and 2 years for patients who undergo cisplatin-based hypofractionated pelvic IMRT? * What is the proportion of patients who complete the treatment in prescribed timeframe? * What the levels of cervix cancer circulating tumor cells pretherapy and after treatment? To confirm eligibility, within four weeks prior to study enrollment, all patients will undergo the following: * Complete history and physical exam, GOG performance status evaluation * Standard of care scans, which include staging CTs and/or PET scans, and MRI to verify eligibility and appropriate stage of disease. Blood tests will be done to check various organ functions. Treatment will be administered on an outpatient basis. The main difference between the proposed regimen in the trial and standard of care is as follows: 1. The trial has a shortened course of EBRT. Standard of care utilizes 25 treatments, also known as "fractions" of EBRT, while the trial utilizes 8 fractions of EBRT. An equivalent "biological effective dose" is achieved by increasing the radiation dose per fraction. 2. The concurrent cisplatin dosing is shortened from 5-6 cycles of cisplatin to 2 cycles of cisplatin. The dose of cisplatin is 40 mg/m2. This protocol requires photon IMRT technique followed by high dose rate (HDR) brachytherapy. The therapies use focused energy beams to kill cancer cells. Radiation therapy must be completed within 30 days +/- 2 days of
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION intensity modulated radiation therapy (IMRT)
- RADIATION high-dose-rate (HDR) brachytherapy
Study Locations (1)
Kentucky
- Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-06-26 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06331468
The ClinicalTrials.gov registry entry for NCT06331468 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denise Fabian, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Uterine Cervix Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT06331468 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT06331468 about?
NCT06331468 is a clinical study titled "Hypofractionated Radiochemotherapy". The goal of this clinical trial is to investigate the use of hypofractionated radiation (delivery of fewer but larger doses of radiation) with concurrent chemotherapy for women with metastatic of bulky uterine cervix cancer. The main questions it aims to answer are: * What is the MRI-assessed rate ...
What is the current status of trial NCT06331468?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-06-26. Estimated completion is 2028-07-01.
What conditions does trial NCT06331468 study?
This clinical trial studies the following conditions: Uterine Cervix Cancer.
What interventions are being tested in trial NCT06331468?
The interventions under investigation include: Cisplatin (DRUG), intensity modulated radiation therapy (IMRT) (RADIATION), high-dose-rate (HDR) brachytherapy (RADIATION).
Who is sponsoring clinical trial NCT06331468?
This trial is sponsored by Denise Fabian, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06331468 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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