A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- Conditions
- Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- Registration Number
- JPRN-UMIN000003670
- Lead Sponsor
- Gynecologic Oncology Trial and Investigation Consortium / Japanese Gynecologic Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 655
Not provided
1) Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer 2) Patients who have received previous chemotherapy or radiation therapy to treat the current disease 3) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study) 4) Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder 5) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil 6) Patients with a pleural effusion requiring continuous drainage 7) Patients with an active infection requiring antibiotics 8) Patients who are pregnant, nursing or of child-bearing potential 9) Patients with evidence upon physical examination of brain tumor and any brain metastases 10) Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason 11) Patients with any signs/symptoms of interstitial pneumonia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PhaseII - Adverse event PhaseIII - Progression Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Overall Suvival Tumor Response Adverse event Treatment completion rate Quality of Life Cost effective