NCT07435376|RecruitingPhase 2
Intra-lesional Tumor Boost for Bulky Cervical Cancer
INTLECTUAL
A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer
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Sponsor study identifier
Secondary identifiers
OTHER · Seould National University Bundang Hospital
interventional
17
1 country
1
Study Start
February 23, 2025
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn if adding a radiation boost (intra-lesional boost) works to treat patients with large-sized cervical cancer. It will also learn about the safety of this treatment. 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.
November 30, 2028
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.
February 23, 2025
Actual (reported)February 20, 2026
Actual (reported)February 27, 2026
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy
Tumor volume is measured using pelvic MRI volumetric analysis to determine if the intra-lesional boost successfully reduces the target volume below 12 cc.
At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)
Complete Remission (CR) Rate
From treatment completion up to 2 years
Locoregional Control Rate
From treatment completion up to 2 years
Patients receive Whole Pelvis (+/- para-aortic field) radiotherapy 45-50.4 Gy in 25-28 fractions. An intra-lesional boost is delivered using SIB technique: 15 Gy in 3 fractions to the boost target (GTVp minus 0.7-1.0 cm margin).
Followed by CT or MRI-based HDR brachytherapy. Recommended dose is 27.5-30 Gy in 4-6 fractions to the HR-CTV using Iridium-192 source.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
First Submitted
February 20, 2026
First Posted
February 27, 2026
Study Start
February 23, 2025
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)Progression-Free Survival (PFS)
From date of enrollment to progression or death, assessed up to 2 years
Overall Survival (OS)
From date of enrollment to death from any cause, assessed up to 2 years
Incidence of Treatment-Related Adverse Events
From the start of treatment up to 2 years
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 27, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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