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Timing of Surgery and Chemotherapy in Advanced Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma
NCT00075712Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2003
- Countries
- 1
- Sponsor
- Royal College of Obstetricians and Gynaecologists
- Modality
- DNA Intercalators/Alkylators
- Conditions
- ovarian cancerprimary peritoneal cancer (PPC)fallopian tube cancer (PFTC)
01
Overview
Phase 3, randomised, open-label trial of carboplatin and paclitaxel in ovarian cancer, primary peritoneal cancer (PPC) and fallopian tube cancer (PFTC) (2 arms), sponsored by Royal College of Obstetricians and Gynaecologists. Primary endpoints: Overall survival at 3 years, Progression-free survival and 1 more. Started Sep 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Primary surgery
Primary radical surgery followed by up to 6 courses of adjuvant chemotherapy
Neoadjuvant chemotherapy
3 courses of neoadjuvant chemotherapy followed by radical surgery and 3 courses of adjuvant chemotherapy
03
Who it enrols
Adult patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer, with clinical and imaging evidence of a pelvic mass with extrapelvic metastases, Serum CA 125/CEA ratio > 25, and plans to receive carboplatin-based chemotherapy.
04
Endpoints
Primary
Overall survival
Progression-free survival
Quality of life
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