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Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer
Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

NCT01462149

CompletedPhase 2

Sponsor: Asan Medical Center

Conditions: Advanced Ovarian Cancer

Interventions: Neoadjuvant chemotherapy, Carboplatin

Countries: South Korea

Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.

Eligibility overview

Sex: FEMALE

Age: 20 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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.
Locations (1)
  • Seoul, South Korea