drugset / Trial / NCT04520074

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

NCT04520074 ↗

Phase 3 Recruiting 590 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2021-10-08
Primary completion
2027-09
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — Intravenous
Subject Cisplatin Other / unclassified 30 mg/m2 Intravenous
Subject Cyclophosphamide Other / unclassified 600 mg Intravenous
Subject Etoposide Small molecule 100 mg Intravenous

Indications