학술논문
Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
Document Type
Article
Author
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
Source
Journal of Gynecologic Oncology (JGO). May 01, 2023 34(3):1
Subject
Language
Korean
English
English
ISSN
2005-0380
Abstract
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.