A Phase III,Randomized, Multi-center, Open Label Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in BRCA1/2 Wide-type Stage III and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after first line of therapy by optimal cytoreductive sugery and 6cycle of TP chemotherapy. There is no standard maintainance therapy for BRCA1/2 wide-type ovarian cancer. We developed an adjuvant chemotherapy of three steps (ACTS). It is adding CTX+VP-16(second step) 6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this study is to verify the effectivity and safety of ACTS in BRCA1/2 wide-type ovarian cancer patients.
• Female patients 18-75 years of age.
• ECOG 0-2
• Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
• FIGO2018 stage III/IV,
• Patients should have received optimal cytoreductive surgery with residual tumor ≤ 1cm and no more than 9 cycle paclitaxel + platinum chemotherapy achieved complete remission (accessed ) and normal CA125.
• No more than 8 months after the last chemotherapy.
• Adequate bone marrow and hepatic function at Screening:
• Hemoglobin ≥9 g/dL
• White blood cell count ≥3.0 × 109/L
• Absolute neutrophil count ≥1.5 × 109/L
• Platelet count ≥100 × 109/L
• AST (SGOT)/ALT (SGPT) ≤2.5 ULN
• Bilirubin \<1.5 × ULN
• Creatinine \<1.5 × ULN.
• Ability and willingness to give written informed consent.
• Tumor BRCA1/2 wilde type (qualified center test)