Epithelial Ovarian Cancer Clinical Trial
Official title:
Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio
to adjuvant chemotherapy or observation groups.
1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous
adenocarcinoma/other histologic types
2. Facility where a subject is enrolled
3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/
Ib vs. Stage Ic(b)
Group A: adjuvant chemotherapy group (standard treatment group):
While one of the following treatments will be performed, the number of cycles is entrusted to
the treatment policy of each facility.
Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA)
area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy;
Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles
After the start of TC therapy, switching from PTX to DTX due to an adverse event is
permitted.
Group B: observation group (study treatment group): Observation only, no adjuvant
chemotherapy administered.
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