18.97.14.81
18.97.14.81
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Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
( Naoya Murakami ) , ( Miho Watanabe ) , ( Takashi Uno ) , ( Shuhei Sekii ) , ( Kayoko Tsujino ) , ( Takahiro Kasamatsu ) , ( Yumiko Machitori ) , ( Tomomi Aoshika ) , ( Shingo Kato ) , ( Hisako Hirowatari ) , ( Yuko Kaneyasu ) , ( Tomio Nakagawa ) , ( Hitoshi Ikushima ) , ( Ken Ando ) , ( Masumi Murata ) , ( Ken Yoshida ) , ( Hiroto Yoshioka ) , ( Kazutoshi Murata ) , ( Tatsuya Ohno ) , ( Noriyuki Okonogi ) , ( Anneyuko I. Saito ) , ( Mayumi Ichikawa ) , ( Takahito Okuda ) , ( Keisuke Tsuchida ) , ( Hideyuki Sakurai ) , ( Ryoichi Yoshimura ) , ( Yasuo Yoshioka ) , ( Atsunori Yorozu ) , ( Naonobu Kunitake ) , ( Hiroyuki Okamoto ) , ( Koji Inaba ) , ( Tomoyasu Kato ) , ( Hiroshi Igaki ) , ( Jun Itami )
UCI I410-ECN-151-24-02-088725388
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Objective: The purposes of this trial were to demonstrate the feasibility and effectiveness of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced cervical cancer patients in the phase I/II prospective clinical trial. Methods: Patients with FIGO stage IB2-IVA uterine cervical cancer pretreatment width of which was ≥5 cm measured by magnetic resonance imaging were eligible for this clinical trial. The protocol therapy included 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP, followed by 24 Gy in 4 fractions of HBT and pelvic radiotherapy with a central shield up to 50-50.4 Gy in 25-28 fractions. The primary endpoint of phase II part was 2-year pelvic progression-free survival (PPFS) rate higher than historical control of 64%. Results: Between October 2015 and October 2019, 73 patients were enrolled in the initial registration and 52 patients proceeded to the secondary registration. With the median follow-up period of 37.3 months (range, 13.9-52.9 months), the 2- PPFS was 80.7% (90% confidence interval [CI]=69.7%-88%). Because the lower range of 90% CI of 2-year PPFS was 69.7%, which was higher than the historical control ICBT data of 64%, therefore, the primary endpoint of this study was met. Conclusion: The effectiveness of HBT were demonstrated by a prospective clinical study. Because the dose goal determined in the protocol was lower than 85 Gy, there is room in improvement for local control. A higher dose might have been needed for tumors with poor responses.

INTRODUCTION
MATERIALS AND METHODS
RESULTS
DISCUSSION
ACKNOWLEDGEMENTS
SUPPLEMENTARY MATERIALS
REFERENCES
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