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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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[Study objectives] To evaluate the efficacy and safety of the combined treatment of radiotherapy and endoscopic intraductal radiofrequency ablation in patients with locoregional extrahepatic cholangiocarcinoma.
â—‹ Study flow The clinical study will be conducted in the following order. Of patients with extrahepatic cholangiocarcinoma requiring biliary drainage, those who meet the inclusion criteria and consent to the study will be enrolled in the study and hospitalized to undergo endoscopic biliary drainage. The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA.
Systemic chemotherapy is also one of the main treatments for patients with inoperable cholangiocarcinoma. Administration of subsequent chemotherapy is recommended after radiotherapy. The choice of chemotherapy regimen is at the discretion of the investigator based on on the patient's age, performance status, and other factors. For older patients who are inoperable, systemic chemotherapy may be difficult to administer.
Tumor response assessment will be performed using CT or MR every 2 months ± 2 weeks based on based on RECIST 1.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The clinical study will be conducted in the following order. Of patients with extrahepatic cholangiocarcinoma requiring biliary drainage, those who meet the inclusion criteria and consent to the study will be enrolled in the study and hospitalized to undergo endoscopic biliary drainage. The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ID-RFA and Radiotherapy | Procedure | The histologic or cytologic examination will be performed at the time of the first biliary drainage, and the extent of the cholangiocarcinoma lesion will be assessed during the procedure. After the diagnosis of extrahepatic cholangiocarcinoma, ID-RFA will be performed, and a biliary stent will be inserted for biliary drainage. Radiotherapy will be performed within 1 month of ID-RFA. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local control rate | 2-year local control rate | At 2 years from the date of study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year local control rate | 1-year local control rate | At 1 years from the date of study enrollment |
| Overall survival | Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Myung Woo, M.D | Contact | 82-31-920-1733 | wsm@ncc.re.kr | |
| Jung Won Chun, M.D | Contact | 82-31-920-0887 | deli4927@ncc.re.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sang Myung Woo, M.D | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Recruiting | Goyang-si | Other | 10408 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30541334 | Result | Prezzano KM, Prasad D, Hermann GM, Belal AN, Alberico RA. Radiofrequency Ablation and Radiation Therapy Improve Local Control in Spinal Metastases Compared to Radiofrequency Ablation Alone. Am J Hosp Palliat Care. 2019 May;36(5):417-422. doi: 10.1177/1049909118819460. Epub 2018 Dec 13. | |
| 24995270 | Result | Hiraki T, Gobara H, Iguchi T, Fujiwara H, Matsui Y, Kanazawa S. Radiofrequency ablation for early-stage nonsmall cell lung cancer. Biomed Res Int. 2014;2014:152087. doi: 10.1155/2014/152087. Epub 2014 Jun 3. |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| The time point of death from any cause from the study enrollment date, whichever occurs first, up to 2 years |
| Progression-free survival | Progression-free survival | The time point of the date of study enrollment until disease progression or death from any cause, whichever occurs first, up to 2 years |
| Local progression-free survival | Local progression-free survival | The time point of the date of study enrollment until locoregional progression or death from any cause, whichever occurs first, up to 2 years |
| Period of Stent patency | Period of Stent patency | The time point of the date of biliary stent placement after ID-RFA to the occurrence of stent dysfunction, up to 2 years |
| 26851032 | Result | Autorino R, Mattiucci GC, Ardito F, Balducci M, Deodato F, Macchia G, Mantini G, Perri V, Tringali A, Gambacorta MA, Tagliaferri L, Giuliante F, Morganti AG, Valentini V. Radiochemotherapy with Gemcitabine in Unresectable Extrahepatic Cholangiocarcinoma: Long-term Results of a Phase II Study. Anticancer Res. 2016 Feb;36(2):737-40. |
| 28958907 | Result | Cho JH, Jeong S, Kim EJ, Kim JM, Kim YS, Lee DH. Long-term results of temperature-controlled endobiliary radiofrequency ablation in a normal swine model. Gastrointest Endosc. 2018 Apr;87(4):1147-1150. doi: 10.1016/j.gie.2017.09.013. Epub 2017 Sep 25. |
| 30439965 | Result | Kim EJ, Chung DH, Kim YJ, Kim YS, Park YH, Kim KK, Cho JH. Endobiliary radiofrequency ablation for distal extrahepatic cholangiocarcinoma: A clinicopathological study. PLoS One. 2018 Nov 15;13(11):e0206694. doi: 10.1371/journal.pone.0206694. eCollection 2018. |
| 29108980 | Result | Sofi AA, Khan MA, Das A, Sachdev M, Khuder S, Nawras A, Lee W. Radiofrequency ablation combined with biliary stent placement versus stent placement alone for malignant biliary strictures: a systematic review and meta-analysis. Gastrointest Endosc. 2018 Apr;87(4):944-951.e1. doi: 10.1016/j.gie.2017.10.029. Epub 2017 Nov 3. |
| 29342492 | Result | Yang J, Wang J, Zhou H, Zhou Y, Wang Y, Jin H, Lou Q, Zhang X. Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial. Endoscopy. 2018 Aug;50(8):751-760. doi: 10.1055/s-0043-124870. Epub 2018 Jan 17. |
| 30861593 | Result | Lee YN, Jeong S, Choi HJ, Cho JH, Cheon YK, Park SW, Kim YS, Lee DH, Moon JH. The safety of newly developed automatic temperature-controlled endobiliary radiofrequency ablation system for malignant biliary strictures: A prospective multicenter study. J Gastroenterol Hepatol. 2019 Aug;34(8):1454-1459. doi: 10.1111/jgh.14657. Epub 2019 Apr 14. |
| 30808323 | Result | Klement RJ, Abbasi-Senger N, Adebahr S, Alheid H, Allgaeuer M, Becker G, Blanck O, Boda-Heggemann J, Brunner T, Duma M, Eble MJ, Ernst I, Gerum S, Habermehl D, Hass P, Henkenberens C, Hildebrandt G, Imhoff D, Kahl H, Klass ND, Krempien R, Lewitzki V, Lohaus F, Ostheimer C, Papachristofilou A, Petersen C, Rieber J, Schneider T, Schrade E, Semrau R, Wachter S, Wittig A, Guckenberger M, Andratschke N. The impact of local control on overall survival after stereotactic body radiotherapy for liver and lung metastases from colorectal cancer: a combined analysis of 388 patients with 500 metastases. BMC Cancer. 2019 Feb 26;19(1):173. doi: 10.1186/s12885-019-5362-5. |
| 22425920 | Result | Machtay M, Paulus R, Moughan J, Komaki R, Bradley JE, Choy H, Albain K, Movsas B, Sause WT, Curran WJ. Defining local-regional control and its importance in locally advanced non-small cell lung carcinoma. J Thorac Oncol. 2012 Apr;7(4):716-22. doi: 10.1097/JTO.0b013e3182429682. |
| 33381458 | Result | Gkika E, Hawkins MA, Grosu AL, Brunner TB. The Evolving Role of Radiation Therapy in the Treatment of Biliary Tract Cancer. Front Oncol. 2020 Dec 14;10:604387. doi: 10.3389/fonc.2020.604387. eCollection 2020. |
| 36460085 | Result | Park N, Jung MK, Kim EJ, Paik WH, Cho JH. In-stent radiofrequency ablation with uncovered metal stent placement for tumor ingrowth/overgrowth causing self-expandable metal stent occlusion in distal malignant biliary obstruction: multicenter propensity score-matched study. Gastrointest Endosc. 2023 Apr;97(4):694-703.e2. doi: 10.1016/j.gie.2022.11.017. Epub 2022 Nov 30. |