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NCT Number: NCT07435376

Intra-lesional 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

Recruiting

Interested in participating?

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

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

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keun-Yong Eom, MD, PhD

CONTACT

[email protected]

82-31-787-7653

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Acronym: INTLECTUAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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