A phase III trial of paclitaxel plus carboplatin versus paclitaxel plus cisplatin in stage IVB, persistent or recurrent cervical cancer: Gynecologic Cancer Study Group/Japan Clinical Oncology Group Study (JCOG0505).
A randomized controlled trial has been started in Japan to compare the utility of palliative chemotherapy containing paclitaxel and carboplatin (TC) with paclitaxel and cisplatin (TP) as a standard treatment for patients with the newly diagnosed Stage IVB, persistent or recurrent cervical cancer who are not amenable to curative treatment with local therapy. This trial was designed to evaluate the non-inferiority of TC as measured by the number of hospitalized days as an indicator of quality of life (QOL) when compared with TP combination therapy. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, response rates, adverse events, severe adverse events and the proportion of non-hospitalization periods compared with planned treatment periods.
Saito
Isamu
I
Clinical Trial and Practice Support Division, Center for Cancer Control and Information Services, National Cancer Center, Tokyo, Japan.
Kitagawa
Ryo
R
Fukuda
Haruhiko
H
Shibata
Taro
T
Katsumata
Noriyuki
N
Konishi
Ikuo
I
Yoshikawa
Hiroyuki
H
Kamura
Toshiharu
T
D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D002985:Clinical Protocols; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D012008:Recurrence; D012107:Research Design; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin