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Clinical Trial
. 2023 May;34(3):e24.
doi: 10.3802/jgo.2023.34.e24. Epub 2022 Dec 21.

Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer

Naoya Murakami  1 , Miho Watanabe  2 , Takashi Uno  2 , Shuhei Sekii  3   4 , Kayoko Tsujino  3 , Takahiro Kasamatsu  5 , Yumiko Machitori  6 , Tomomi Aoshika  7 , Shingo Kato  7 , Hisako Hirowatari  8 , Yuko Kaneyasu  9 , Tomio Nakagawa  9 , Hitoshi Ikushima  10 , Ken Ando  11   12 , Masumi Murata  11 , Ken Yoshida  13   14 , Hiroto Yoshioka  13 , Kazutoshi Murata  12   15 , Tatsuya Ohno  12 , Noriyuki Okonogi  15 , Anneyuko I Saito  16 , Mayumi Ichikawa  17 , Takahito Okuda  18 , Keisuke Tsuchida  19 , Hideyuki Sakurai  20 , Ryoichi Yoshimura  21 , Yasuo Yoshioka  22 , Atsunori Yorozu  23 , Naonobu Kunitake  24 , Hiroyuki Okamoto  25 , Koji Inaba  26 , Tomoyasu Kato  27 , Hiroshi Igaki  28 , Jun Itami  26
Affiliations
Clinical Trial

Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer

Naoya Murakami et al. J Gynecol Oncol. 2023 May.

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.

Keywords: Cervical Cancer; IC/IS; Image Guided Adaptive Brachytherapy; Intracavitary and Interstitial Brachytherapy.

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Conflict of interest statement

Dr. Itami reports personal fees from HekaBio, grants and personal fees from Itochu, grants from Elekta, personal fees from AlphaTAU, personal fees from ViewRay, personal fees from Palette Science, outside the submitted work.

Figures

Fig. 1
Fig. 1. The study’s CONSORT flow diagram is depicted in Fig. 1. This diagram shows the patient flow throughout the trial.
BT, brachytherapy; EBRT, external beam radiation therapy; Plt, platelet ;WBC, white blood cell.
Fig. 2
Fig. 2. Figure 2 shows progression-free survival, overall survival, local control, and pelvic progression-free survival curves.
See this image and copyright information in PMC

References

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