Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
NCT ID: NCT01462149
Last Updated: 2017-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2011-10-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy
Neoadjuvant chemotherapy with docetaxel plus carboplatin
Neoadjuvant chemotherapy
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
Carboplatin
Carboplatin AUC 5, q 3 weeks, 3 cycles
Interventions
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Neoadjuvant chemotherapy
Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
Carboplatin
Carboplatin AUC 5, q 3 weeks, 3 cycles
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
20 Years
80 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Jong-Hyeok Kim
Professor
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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NEODOCA-OVCA
Identifier Type: -
Identifier Source: org_study_id
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