Abstract
Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperitoneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-free survival and secondary endpoints include overall survival, quality of life assessment and cost-benefit. The first 120 patients will be evaluated for the feasibility of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.
| Original language | English |
|---|---|
| Pages (from-to) | 278-282 |
| Number of pages | 5 |
| Journal | Japanese Journal of Clinical Oncology |
| Volume | 41 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 2011 Feb |
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Keywords
- Carboplatin
- Dose-dense chemotherapy
- Intraperitoneal chemotherapy
- Ovarian cancer
- Paclitaxel
ASJC Scopus subject areas
- Oncology
- Cancer Research
- Radiology Nuclear Medicine and imaging
Cite this
A randomized phase II/III trial of 3 weekly intraperitoneal versus intravenous carboplatin in combination with intravenous weekly dose-dense paclitaxel for newly diagnosed ovarian, fallopian tube and primary peritoneal cancer. / Fujiwara, Keiichi; Aotani, Eriko; Hamano, Tetsutaro; Nagao, Shoji; Yoshikawa, Hiroyuki; Sugiyama, Toru; Kigawa, Junzo; Aoki, Daisuke; Katsumata, Noriyuki; Takeuchi, Masahiro; Suzuki, Mitsuaki.
In: Japanese Journal of Clinical Oncology, Vol. 41, No. 2, 02.2011, p. 278-282.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized phase II/III trial of 3 weekly intraperitoneal versus intravenous carboplatin in combination with intravenous weekly dose-dense paclitaxel for newly diagnosed ovarian, fallopian tube and primary peritoneal cancer
AU - Fujiwara, Keiichi
AU - Aotani, Eriko
AU - Hamano, Tetsutaro
AU - Nagao, Shoji
AU - Yoshikawa, Hiroyuki
AU - Sugiyama, Toru
AU - Kigawa, Junzo
AU - Aoki, Daisuke
AU - Katsumata, Noriyuki
AU - Takeuchi, Masahiro
AU - Suzuki, Mitsuaki
PY - 2011/2
Y1 - 2011/2
N2 - Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperitoneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-free survival and secondary endpoints include overall survival, quality of life assessment and cost-benefit. The first 120 patients will be evaluated for the feasibility of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.
AB - Retrospective studies and a Phase II trial demonstrated the promising efficacy and safety of intraperitoneal administration of carboplatin in ovarian, fallopian tube and primary peritoneal cancer. A Japanese Gynecologic Oncology Group 3016 randomized Phase III trial for these cancers showed dose-dense weekly administration of paclitaxel significant improvement of progression-free survival and overall survival over every 3-week administration. From June 2010, we have been conducting a randomized Phase II/III trial of intravenous versus intraperitoneal administration of carboplatin every 3 week in combination with dose-dense weekly administration of paclitaxel. The purpose of this trial is to prove the superiority of intraperitoneal administration of carboplatin over intravenous administration. Primary endpoint is progression-free survival and secondary endpoints include overall survival, quality of life assessment and cost-benefit. The first 120 patients will be evaluated for the feasibility of intraperitoneal arm and a total of 746 patients will be enrolled in a Phase III study.
KW - Carboplatin
KW - Dose-dense chemotherapy
KW - Intraperitoneal chemotherapy
KW - Ovarian cancer
KW - Paclitaxel
UR - http://www.scopus.com/inward/record.url?scp=79251635492&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79251635492&partnerID=8YFLogxK
U2 - 10.1093/jjco/hyq182
DO - 10.1093/jjco/hyq182
M3 - Article
VL - 41
SP - 278
EP - 282
JO - Japanese Journal of Clinical Oncology
JF - Japanese Journal of Clinical Oncology
SN - 0368-2811
IS - 2
ER -