Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer
© 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology..
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.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:34 |
|---|---|
| Enthalten in: |
Journal of gynecologic oncology - 34(2023), 3 vom: 23. Mai, Seite e24 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Murakami, Naoya [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Cervical Cancer |
|---|
| Anmerkungen: |
Date Completed 04.05.2023 Date Revised 06.05.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.3802/jgo.2023.34.e24 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM351150064 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM351150064 | ||
| 003 | DE-627 | ||
| 005 | 20231226050644.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3802/jgo.2023.34.e24 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1170.xml |
| 035 | |a (DE-627)NLM351150064 | ||
| 035 | |a (NLM)36603849 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Murakami, Naoya |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Phase I/II prospective clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced uterine cervical cancer |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 04.05.2023 | ||
| 500 | |a Date Revised 06.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology. | ||
| 520 | |a 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 | ||
| 520 | |a 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% | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Clinical Trial, Phase I | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cervical Cancer | |
| 650 | 4 | |a IC/IS | |
| 650 | 4 | |a Image Guided Adaptive Brachytherapy | |
| 650 | 4 | |a Intracavitary and Interstitial Brachytherapy | |
| 700 | 1 | |a Watanabe, Miho |e verfasserin |4 aut | |
| 700 | 1 | |a Uno, Takashi |e verfasserin |4 aut | |
| 700 | 1 | |a Sekii, Shuhei |e verfasserin |4 aut | |
| 700 | 1 | |a Tsujino, Kayoko |e verfasserin |4 aut | |
| 700 | 1 | |a Kasamatsu, Takahiro |e verfasserin |4 aut | |
| 700 | 1 | |a Machitori, Yumiko |e verfasserin |4 aut | |
| 700 | 1 | |a Aoshika, Tomomi |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Shingo |e verfasserin |4 aut | |
| 700 | 1 | |a Hirowatari, Hisako |e verfasserin |4 aut | |
| 700 | 1 | |a Kaneyasu, Yuko |e verfasserin |4 aut | |
| 700 | 1 | |a Nakagawa, Tomio |e verfasserin |4 aut | |
| 700 | 1 | |a Ikushima, Hitoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ando, Ken |e verfasserin |4 aut | |
| 700 | 1 | |a Murata, Masumi |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshida, Ken |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshioka, Hiroto |e verfasserin |4 aut | |
| 700 | 1 | |a Murata, Kazutoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Ohno, Tatsuya |e verfasserin |4 aut | |
| 700 | 1 | |a Okonogi, Noriyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Saito, Anneyuko I |e verfasserin |4 aut | |
| 700 | 1 | |a Ichikawa, Mayumi |e verfasserin |4 aut | |
| 700 | 1 | |a Okuda, Takahito |e verfasserin |4 aut | |
| 700 | 1 | |a Tsuchida, Keisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Sakurai, Hideyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshimura, Ryoichi |e verfasserin |4 aut | |
| 700 | 1 | |a Yoshioka, Yasuo |e verfasserin |4 aut | |
| 700 | 1 | |a Yorozu, Atsunori |e verfasserin |4 aut | |
| 700 | 1 | |a Kunitake, Naonobu |e verfasserin |4 aut | |
| 700 | 1 | |a Okamoto, Hiroyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Inaba, Koji |e verfasserin |4 aut | |
| 700 | 1 | |a Kato, Tomoyasu |e verfasserin |4 aut | |
| 700 | 1 | |a Igaki, Hiroshi |e verfasserin |4 aut | |
| 700 | 1 | |a Itami, Jun |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Journal of gynecologic oncology |d 2008 |g 34(2023), 3 vom: 23. Mai, Seite e24 |w (DE-627)NLM188802258 |x 2005-0399 |7 nnns |
| 773 | 1 | 8 | |g volume:34 |g year:2023 |g number:3 |g day:23 |g month:05 |g pages:e24 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3802/jgo.2023.34.e24 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 34 |j 2023 |e 3 |b 23 |c 05 |h e24 | ||