Status:
RECRUITING
Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
Lead Sponsor:
Fudan University
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
More than 70 percent of ovarian cancer patients were diagnosed in the advanced stage. Currently the 5-year disease free survival (DFS) of stageⅢ-Ⅳovarian cancer patients was about 10 percent after fir...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2030
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT04520074
Start Date
October 8 2021
End Date
September 1 2030
Last Update
July 27 2022
Active Locations (1)
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1
Wu Xiaohua
Shanghai, Shanghai Municipality, China, 200023