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Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
Radiotherapy
intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensity-modulated radiotheapy arm | Experimental | Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose Intensity-modulated radiotherapy | Radiation | Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression means locoregional recurrence, distant metastasis, and local tumor pregression | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 30 months | |
| Treatment-related adverse events are assessed by CTCAE v4.0. | Toxicity | acute within 3 months and chronic after 3 months after radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Hoon Lee, MD | Contact | +82-010-8607-1269 | koppul@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jong Hoon Lee, MD | St. Vincent's Hospital, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lee Jong Hoon | Recruiting | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38530569 | Derived | Kang HB, Kim SH, Lee JH, Lee HC, Kang NK, Lee JH. MRI-based volumetric tumor parameters before and during chemoradiation predict tumor recurrence and patient survival in locally advanced cervical cancer: a subgroup analysis of a phase II prospective trial. Int J Clin Oncol. 2024 May;29(5):620-628. doi: 10.1007/s10147-024-02490-7. Epub 2024 Mar 26. | |
| 37689018 |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Lee HC, Jeong JW, Lee JH, Kim SH, Park DC, Yoon JH, Kim SI, Lee JH. High-dose (60 Gy) intensity-modulated radiotherapy with concurrent weekly cisplatin followed by intracavitary radiation in locally advanced cervical cancer: A phase II prospective clinical trial. Gynecol Oncol. 2023 Oct;177:142-149. doi: 10.1016/j.ygyno.2023.08.018. Epub 2023 Sep 7. |