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- W4310691243 abstract "<h3>Purpose</h3> To evaluate the tolerability, safety and efficacy of KORTUC Intratumoral injection with brachytherapy in unresectable recurrent cervical cancer. <h3>Materials and Methods</h3> A novel radiosensitizer KORTUC (Kochi Oxydol Radiation Therapy for Unresectable Carcinoma) was invested by Dr. Yasuhiro Ogawa at Kochi University (Japan) in 2006 and was developed for the treatment of malignant solid tumours that contain numerous hypoxic cancer cells and/or large quantities of antioxidative enzymes. Hydrogen peroxide is the only agent known to be capable of inactivating antioxidative enzymes and producing oxygen simultaneously when applied to tumour tissues. KORTUC is a solution that contains 3% hydrogen peroxide with 1% sodium hyaluronate. Hydrogen peroxide is the active ingredient for this radiosensitizer. Sodium hyaluronate viscosity sustains the hydrogen peroxide in the tumour as well as delays decomposition of hydrogen peroxide and maintains a high concentration of oxygen in the tumour. Injecting the two components together at a particular ratio is the key feature of this product. Currently Phase 2 clinical trial for locally advanced and recurrent breast cancer has been conducted in the United Kingdom and India. Our institution, (Osaka Medical and Pharmaceutical University, Japan) has conducted single-arm clinical research of KORTUC since May 2010, we dosed KORTUC more than 250 patients of various solid cancers including more than 40 patients of the gynecological tumors treated with brachytherapy as of today. In this study we report our experiences of KORTUC with brachytherapy in recurrent local advanced cervical cancer patients who are likely the high risk of poor prognosis.From April 2012 to January 2020, 15 female patients with recurrent cervical cancer received KORTUC with brachytherapy. Previous treatments of 15 recurrent patients were surgery (n=4), radiation therapy (n=8), surgery + radiation therapy (n=3). The primary lesion of these 15 patients were vaginal stump (n=5), pelvic wall (n=3), cervix (n=3), vaginal wall (n=2), and lymph node (n=2). KORTUC was injected intratumorally under direct vision of colposcopy prior to radiation therapy. The dose of KORTUC ranged from 4 to 12 mL adjusted by tumor size. For patients who had the Interstitial brachytherapy, KORTUC was administered before and after the applicator insertion prior to irradiation. <h3>Results</h3> Intratumoral injection of KORTUC was completed without any technical and safety issues in all 15 patients. KORTUC was well tolerated and no adverse events judged to be related to KORTUC injection were observed, except the transient local pain at the injection site in some patients. KORTUC also showed efficacy in local control in recurrent patients. <h3>Conclusion</h3> Based on this result, we would like to confirm in a future study, KORTUC's efficacy with external irradiation as well as brachytherapy for the newly diagnosed unresectable locally advanced cervical cancer with high risk factors of poor prognosis. KORTUC may have potential as an effective radiation response enhancer in multiple cancer types in which locoregional control after RT alone remains poor." @default.
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- W4310691243 date "2022-11-01" @default.
- W4310691243 modified "2023-09-28" @default.
- W4310691243 title "GSOR22 Presentation Time: 12:15 PM" @default.
- W4310691243 doi "https://doi.org/10.1016/j.brachy.2022.09.091" @default.
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