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| ID | Type | Description | Link |
|---|---|---|---|
| B-2410-931-001 | Other Identifier | Seould National University Bundang Hospital |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-lesional Boost Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission (CR) Rate | Defined as the disappearance of all lesions on cervical examination and imaging tests. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keun-Yong Eom, MD, PhD | Contact | 82-31-787-7653 | 978sarang@snubh.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 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. |
|
| From treatment completion up to 2 years |
| Progression-Free Survival (PFS) | Assessed using the Kaplan-Meier method. | From date of enrollment to progression or death, assessed up to 2 years |
| Overall Survival (OS) | 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 | Assessed and graded according to NCI-CTCAE version 6.0. | From the start of treatment up to 2 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |