Intra-lesional Tumor Boost for Bulky Cervical Cancer

NCT07435376 | Recruiting Phase 2

• 2 other identifiers: KROG 24-03B-2410-931-001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cervical cancer; bulky cervical cancer; squamous cell carcinoma; intra lesional boost; simultaneous integrated boost; imrt; radiotherapy; tumor volume reduction

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Complete Remission (CR) Rate

  From treatment completion up to 2 years

• Locoregional Control Rate

  From treatment completion up to 2 years

• 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

Study Arms (1)

Intra-lesional Boost Group

EXPERIMENTAL

Radiation: intra-lesional boost IMRT; Procedure: High Dose Rate Brachytherapy

Interventions

intra-lesional boost IMRT RADIATION

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).

Intra-lesional Boost Group

High Dose Rate Brachytherapy PROCEDURE

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.

Intra-lesional Boost Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Central Study Contacts

Keun-Yong Eom, MD, PhD

CONTACT

82-31-787-7653; 978sarang@snubh.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 23, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)