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Phase II Trial of Hypofractionated Radiochemotherapy for Women With Metastatic or Bulky Uterine Cervix Cancer
Sponsor study identifier
interventional
20
1 country
1
Study Start
June 26, 2025
Actual (reported)Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 19, 2024
Actual (reported)March 26, 2024
Actual (reported)June 26, 2025
Actual (reported)July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
MRI assessed rate of complete response
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
1 month post treatment (day 60)
MRI assessed rate of complete response
3 months post treatment (day 120)
progression-free survival (PFS)
up to 2 years
overall survival (OS)
up to 2 years
Treatment Completion
up to 32 days
Treatment Tolerability
up to 2 years
Change in levels of uterine cervix cancer circulating tumor cells
pre-treatment; 1-month post-treatment completion (Day 60); and 3-mos post-treatment completion (Day 120)
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
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.
Markey Cancer Center
Lexington, Kentucky, 40506, United States
Denise Fabian, MD
University of Kentucky
Denise Fabian, MD
CONTACT
First Submitted
March 19, 2024
First Posted
March 26, 2024
Study Start
June 26, 2025
Actual (reported)Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
given once daily Monday-Thursday, four fractions per week for 2 weeks. The radiation dose is 4.56 Gy x 8 fractions.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
July 1, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 30, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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