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Clinical Trials in China / NCT04520074
Recruiting Phase 3

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

NCT04520074 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 3
Started
2021-10-08
Last updated
2022-07-27

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Etoposide, Cyclophosphamide, Carboplatin/Cisplatin

Etoposide, Cyclophosphamide, Carboplatin/Cisplatin: CTX 400mg(250mg/m2)+VP-16 100mg (70mg/m2)d1-d3 iv 4w/6cycles , CBP(AUC=5) d1/CDDP 30mg/m2 d1-d2+CTX 600mg(400mg/m2)d1-d2 iv 8w/6cycles

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * 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) Exclusion Criteria: * Primary or secondary immune deficiency. * Any uncontrolled medical condition that may put the patient at high risk during treatment . * Receipt of any other investigational medicinal product within the last 30 days before randomization. * Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years. * Severe heart/ lung/ liver/ kidney failure. * uncontroled or active infection disease. * Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons. * Receipt of pelvic or abdominal radiotherapy * Mucinous adenocarcinoma, low grade carcinoma

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wu Xiaohua Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04520074 on ClinicalTrials.gov ↗ ← All trials in China