Cervical CancerPhase 2INTLECTUALNCT07435376
Intra-lesional Tumor Boost for Bulky Cervical Cancer
A Phase 2 study testing intra-lesional boost IMRT and High Dose Rate Brachytherapy in people with Cervical Cancer and Squamous Cell Carcinoma of Cervix, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Squamous Cell Carcinoma of Cervix
- What is being tested?
- intra-lesional boost IMRT and High Dose Rate Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Feb 2025to 30 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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?
Read more
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
- Being tested
- intra-lesional boost IMRT, High Dose Rate Brachytherapy
- Keywords
- cervical cancer, bulky cervical cancer, squamous cell carcinoma, intra lesional boost, simultaneous integrated boost, imrt, radiotherapy, tumor volume reduction
- Medical subject headings
- Uterine Cervical Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-lesional boost IMRTRadiation
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 BrachytherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra-lesional Boost Group | Experimental | Not described Receives: Radiation: intra-lesional boost IMRT; Procedure: High Dose Rate Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Defined as the disappearance of all lesions on cervical examination and imaging tests.
Measured: From treatment completion up to 2 years
Locoregional Control Rate
Defined as the absence of tumor recurrence in the locoregional area confirmed by biopsy or imaging.
Measured: From treatment completion up to 2 years
Progression-Free Survival (PFS)
Assessed using the Kaplan-Meier method.
Measured: From date of enrollment to progression or death, assessed up to 2 years
Overall Survival (OS)
Assessed using the Kaplan-Meier method.
Measured: From date of enrollment to death from any cause, assessed up to 2 years
Incidence of Treatment-Related Adverse Events
Assessed and graded according to NCI-CTCAE version 6.0.
Measured: From the start of treatment up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Feb 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KEUN YONG EOM, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435376
- Sponsor's protocol ID
- KROG 24-03
- Other IDs
- B-2410-931-001
- Acronym
- INTLECTUAL
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase 2 Clinical Trial of Intra-lesional Cervical Tumor Boost for Bulky Cervical Cancer
- ClinicalTrials.gov ID
- NCT07435376
- Acronym / sponsor ID
- INTLECTUAL / KROG 24-03
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 23 Feb 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-lesional Boost Group | Experimental | Radiation: intra-lesional boost IMRT, Procedure: High Dose Rate Brachytherapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-lesional boost IMRTPatients 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). | Radiation | Intra-lesional Boost Group |
| High Dose Rate BrachytherapyFollowed 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. | Procedure or surgery | Intra-lesional Boost Group |
Primary outcome
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.
5 secondary outcomes
Complete Remission (CR) Rate
Time frame: From treatment completion up to 2 years
Locoregional Control Rate
Time frame: 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
Overall Survival (OS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intra-lesional boost IMRT and High Dose Rate Brachytherapy in people with Cervical Cancer and Squamous Cell Carcinoma of Cervix, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keun-Yong Eom, MD, PhD (82-31-787-7653, 978sarang@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.