Randomized phase II/III trial comparing dose-dense Paclitaxel and Carboplatin (TC) therapy and conventional triweekly TC therapy for newly diagnosed or recurrent uterine carcinosarcoma
- Conditions
- uterine carcinosarcoma
- Registration Number
- JPRN-UMIN000025884
- Lead Sponsor
- Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 400
Not provided
1)Patients with infectious disease requiring antimicrobial agent. 2)Patients who have undergone chenotherapy for the primary disease. 3)Patients with a history of other invasive malignancies, with the exception of intraepithelial carcinoma of the uterine cervix, non-melanoma skin cancer, if there is any evidence of other malignancy being present within the last 5 years. Patients are also excluded if their previous cancer treatment contraindicates this protocoltherapy. 4)Patients with serious complication (e.g. heart disease, uncontrollable diabetes mellitus, malignant hypertension, bleeding tendency). 5)Patients with active multiple cancers. 6)Patients with pneumonitis or pulmonary fibrosis. 7)Patients with fluid retention requiring treatment. 8)Patients with repeated gastrointestinal bleeding requiring blood products. 9)Patients with a history of unstable angina or myocardial infarction within 6 months before registration, or with complicated severe arrhythmia requiring treatment. However, patients with abnormal cardiac conduction system (e.g. fascicular block, bundle branch block) who have been stable for 6 months before registration is not excluded. 10)Patients who have a contraindication to paclitaxel and carboplatin. 11)Patients with intestinal paralysis or ileus. 12)Patients with a history of severe drug hypersensitivity or allergy. 13)Patients who have been judged to be inappropriate for this study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method