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

• Status: Not yet recruiting
• Trial end date: 2030-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Carboplatin; Cyclophosphamide; Etoposide

Criteria

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