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OncoMatch/Clinical Trials/NCT04520074

Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)

Is NCT04520074 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Etoposide, Cyclophosphamide, Carboplatin/Cisplatin for ovarian cancer.

Phase 3RecruitingFudan UniversityNCT04520074Data as of May 2026

Treatment: Etoposide, Cyclophosphamide, Carboplatin/CisplatinOvarian 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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: BRCA1 wild-type

Required: BRCA2 wild-type

Disease stage

Required: Stage III, IV

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: cytoreductive surgery

optimal cytoreductive surgery with residual tumor ≤ 1cm

Must have received: platinum-based chemotherapy (paclitaxel)

no more than 9 cycle paclitaxel + platinum chemotherapy achieved complete remission

Cannot have received: pelvic or abdominal radiotherapy

Receipt of pelvic or abdominal radiotherapy

Cannot have received: investigational medicinal product

Receipt of any other investigational medicinal product within the last 30 days before randomization

Lab requirements

Blood counts

Hemoglobin ≥9 g/dL; White blood cell count ≥3.0 × 10^9/L; Absolute neutrophil count ≥1.5 × 10^9/L; Platelet count ≥100 × 10^9/L

Kidney function

Creatinine <1.5 × ULN

Liver function

AST (SGOT)/ALT (SGPT) ≤2.5 ULN; Bilirubin <1.5 × ULN

Adequate bone marrow and hepatic function at Screening: * Hemoglobin ≥9 g/dL * White blood cell count ≥3.0 × 10^9/L * Absolute neutrophil count ≥1.5 × 10^9/L * Platelet count ≥100 × 10^9/L * AST (SGOT)/ALT (SGPT) ≤2.5 ULN * Bilirubin <1.5 × ULN * Creatinine <1.5 × ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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