Status:
COMPLETED
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Advanced Ovarian Cancer
Eligibility:
FEMALE
20-80 years
Phase:
PHASE2
Brief Summary
Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic reg...
Eligibility Criteria
Inclusion
- Advanced epithelial, tubal, or primary peritoneal cancer
- Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery
- Less probability of complete cytoreduction
- Age: 20-80 years
- GOG performance status: 0-3
- Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3
Exclusion
- Previous chemotherapy or pelvic radiation therapy
- Final diagnosis is other malignancies
- Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix
- History of severe allergy
- Pregnancy, lactating woman
- Uncontrolled medial disease
- Bowel obstruction requiring immediate surgery
- Etc.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01462149
Start Date
October 1 2011
End Date
June 1 2016
Last Update
May 31 2017
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 138-736