Randomized Phase II/III Trial of Conventional Paclitaxel and Carboplatin with/without Bevacizumab versus Dose-dense Paclitaxel and Carboplatin with/without Bevacizumab in Stage IVB, Recurrent, or Persistent Cervical Carcinoma (JCOG1311, CC-TC/ddTC-P2/3)
- Conditions
- Metastatic or Recurrent Cervical Carcinoma, not amenable to curative surgery or radiotherapy
- Registration Number
- JPRN-UMIN000019191
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- Female
- Target Recruitment
- 420
Not provided
(1) Simultaneous or metachronous (within 5 years) double cancers. (2) Active systemic infections to be treated. (3) Body temperature of 38 or more degrees Celsius (4) Women during pregnancy, possible pregnancy, or breast-feeding (5) Psychiatric disease (6) Continuous systemic steroid treatment (7) Uncontrolled diabetes mellitus or routine administration of insulin (8) Uncontrolled hypertension (9) Unstable angina or prior myocardial infarction with in 6 months (10) Metastasis to central nerve system with a symptom (11) Interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema (12) HBs antigen positive, HCV antibody positive, HIV antibody positive (13) hypersensitivity to polyoxyethylated castor oil (14) hypersensitivity to alcohol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase II: Response Rate (Assessed in the following timing: i) day 15-21 in the 3rd course, ii) day 15-21 in the 6th course, iii) day 22-56 in the last course (day 1 denotes the initial date of each course)), Phase III: Overall Survival
- Secondary Outcome Measures
Name Time Method Phase II: Adverse Events, Serious Adverse Events Phase III: Progression-free Survival, Response Rate, Adverse Events, Serious Adverse Events, Proportion of periods of non-hospitalization to those of the planned treatment during the first 6 courses