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Intra-lesional Tumor Boost for Bulky Cervical Cancer

NCT07435376 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-02-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-23
Primary Completion
2026-09-30
Completion
2028-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07435376 on ClinicalTrials.gov