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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 (Jun 2026). This Phase 3 trial studies Etoposide, Cyclophosphamide, Carboplatin/Cisplatin for ovarian cancer.

Phase 3RecruitingFudan UniversityNCT04520074Data as of Jun 2026Location: China

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

Treatments studied

Chemotherapy

Etoposide, Cyclophosphamide, Carboplatin/Cisplatin

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)

Demographics

Ages ≤ 75
Female only

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.

Frequently asked questions

Is NCT04520074 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior pelvic or abdominal radiotherapy, investigational medicinal product disqualifies patients from enrollment.

Does this trial require BRCA1?

Yes, BRCA1 wild-type is a required biomarker for enrollment.

Does this trial require BRCA2?

Yes, BRCA2 wild-type is a required biomarker for enrollment.

What disease stage is eligible?

Stage III or IV is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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