Intra-lesional Tumor Boost for Bulky Cervical Cancer (INTLECTUAL)

February 20, 2026 updated by: KEUN YONG EOM, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with histologically confirmed squamous cell carcinoma of the cervix.
  • Patients with bulky primary tumor, defined as a tumor volume ≥ 60 cc OR a maximum diameter ≥ 6 cm.
  • Patients aged 19 to 80 years at the time of diagnosis.
  • Patients with an ECOG performance status of 0 to 2.
  • Patients who have voluntarily agreed to participate in the study.

Exclusion Criteria:

  • Diagnosis of other malignancies within 5 years prior to enrollment (Exceptions: carcinoma in situ of the breast and thyroid cancer).
  • Patients who are medically unfit for definitive concurrent chemoradiotherapy.
  • Patients who have received prior chemotherapy (neoadjuvant chemotherapy) before radiation therapy.
  • Patients with prior history of radiation therapy to the abdomen or pelvis.
  • Patients unable to provide informed consent due to mental or physical disabilities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intra-lesional Boost Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With Tumor Volume < 12 cc Before Brachytherapy
Time Frame: At 4 to 5 weeks after the start of radiation therapy (specifically at the time of 20-25 fractions)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission (CR) Rate
Time Frame: From treatment completion up to 2 years
Defined as the disappearance of all lesions on cervical examination and imaging tests.
From treatment completion up to 2 years
Locoregional Control Rate
Time Frame: From treatment completion up to 2 years
Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging.
From treatment completion up to 2 years
Progression-Free Survival (PFS)
Time Frame: From date of enrollment to progression or death, assessed up to 2 years
Assessed using the Kaplan-Meier method.
From date of enrollment to progression or death, assessed up to 2 years
Overall Survival (OS)
Time Frame: From date of enrollment to death from any cause, assessed up to 2 years
Assessed using the Kaplan-Meier method.
From date of enrollment to death from any cause, assessed up to 2 years
Incidence of Treatment-Related Adverse Events
Time Frame: From the start of treatment up to 2 years
Assessed and graded according to NCI-CTCAE version 6.0.
From the start of treatment up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KROG 24-03
  • B-2410-931-001 (Other Identifier: Seould National University Bundang Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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