|
KMID : 1137020230340030024
|
|
Journal of Gynecologic Oncology
2023 Volume.34 No. 3 p.24 ~ p.24
|
|
|
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
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
|
|
|
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.
|
|
|
KEYWORD
|
|
|
Cervical Cancer, Image Guided Adaptive Brachytherapy, Intracavitary and Interstitial Brachytherapy, IC/IS
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
    
|