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Decitabine + Carboplatin-Paclitaxel in First-Line Advanced Ovarian Cancer
NCT02159820Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2014
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Chinese PLA General Hospital
- Modality
- Small Molecules
- Drugs
- decitabine
- Conditions
- ovarian cancerfallopian tube cancer (PFTC)primary peritoneal cancer (PPC)
01
Overview
Phase 3, randomised, open-label trial of decitabine in ovarian cancer, fallopian tube cancer (PFTC) and primary peritoneal cancer (PPC) (2 arms), sponsored by Chinese PLA General Hospital. Primary endpoints: Progression-free survival at 20 months, Overall survival rate at 30 months and 2 more. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
DTC Arm
Decitabine + Paclitaxel + Carboplatin
TC Arm
Paclitaxel + Carboplatin
03
Who it enrols
Patients with histologically confirmed FIGO stage II-IV ovarian, fallopian tube, or primary peritoneal cancer, ECOG 0-3, and no prior chemotherapy.
04
Endpoints
Primary
Progression-free survival
Overall survival rate
Overall response rate
Toxicity
Secondary
Pharmacokinetics of lower-dose decitabine
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