NCT07435376

Intra-lesional Tumor Boost for Bulky Cervical Cancer

A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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: * Does the extra radiation boost effectively reduce the tumor size before the internal radiation (brachytherapy) treatment begins? * What medical problems (side effects) do participants have when receiving this treatment? Researchers will give this intra-lesional boost to all participants during their standard radiation therapy to see if it helps shrink the tumor more than usual. Participants will: * Receive radiation therapy to the pelvis with a targeted boost to the tumor for about 5 to 6 weeks * Visit the clinic daily for radiation treatment and regularly for checkups Have an MRI scan during the 4th or 5th week of treatment to measure the tumor size * Receive internal radiation therapy (brachytherapy) after finishing the external radiation * Visit the clinic for follow-up checkups and tests for up to 2 years

Conditions

• Cervical Cancer
• Squamous Cell Carcinoma of Cervix

Interventions

Type	Name	Description
RADIATION	intra-lesional boost IMRT	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).
PROCEDURE	High Dose Rate Brachytherapy	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.

Timeline

• Start date: 2025-02-23
• Primary completion: 2026-09-30
• Completion: 2028-11-30
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: South Korea