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A randomized phase II/III trial of conventional paclitaxel and carboplatin with or without bevacizumab vs dose-dense paclitaxel and carboplatin with or without bevacizumab, in stage IVB, recurrent or persistent cervical carcinoma: Japan Clinical Oncology Group Study (JCOG1311).
- Source :
-
Japanese journal of clinical oncology [Jpn J Clin Oncol] 2018 Dec 01; Vol. 48 (12), pp. 1096-1100. - Publication Year :
- 2018
-
Abstract
- A randomized controlled trial has been initiated to compare chemotherapy containing dose-dense paclitaxel plus carboplatin with or without bevacizumab to a conventional regimen containing tri-weekly paclitaxel plus carboplatin with or without bevacizumab. Eligible patients are those with stage IVB, recurrent or persistent cervical carcinoma not amenable to curative treatment with local therapy. Patients are randomly assigned to either the conventional or dose-dense regimen. However, patients who are at increased risk of adverse events following bevacizumab administration will not receive this drug. The primary endpoint of phase II part is response rate. If the response rate of the dose-dense regimen is better than that of conventional regimen, this study will proceed to phase III, where the primary endpoint is overall survival. Secondary endpoints in phase III part are progression-free survival, response rates, adverse events, serious adverse events and the proportion of non-hospitalization periods compared with planned treatment periods.
- Subjects :
- Adult
Aged
Antineoplastic Combined Chemotherapy Protocols administration & dosage
Antineoplastic Combined Chemotherapy Protocols pharmacology
Bevacizumab administration & dosage
Bevacizumab pharmacology
Carboplatin administration & dosage
Carboplatin pharmacology
Female
Humans
Japan
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Paclitaxel administration & dosage
Paclitaxel pharmacology
Uterine Cervical Neoplasms pathology
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Bevacizumab therapeutic use
Carboplatin therapeutic use
Paclitaxel therapeutic use
Uterine Cervical Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1465-3621
- Volume :
- 48
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Japanese journal of clinical oncology
- Publication Type :
- Academic Journal
- Accession number :
- 30295796
- Full Text :
- https://doi.org/10.1093/jjco/hyy137