Actively Recruiting
Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
Led by Fudan University · Updated on 2022-07-27
590
Participants Needed
1
Research Sites
464 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- ECOG performance status of 0 to 2
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer
- FIGO 2018 stage III or IV disease
- Optimal cytoreductive surgery with residual tumor 1 cm or less
- Completed no more than 9 cycles of paclitaxel plus platinum chemotherapy with complete remission and normal CA125
- No more than 8 months since last chemotherapy
- Adequate bone marrow and liver function: hemoglobin 9 g/dL, white blood cell count �b53.0 �d7 109/L, absolute neutrophil count �b51.5 �d7 109/L, platelet count �b5100 �d7 109/L, AST/ALT �b42.5 times upper limit, bilirubin less than 1.5 times upper limit, creatinine less than 1.5 times upper limit
- Ability and willingness to provide written informed consent
- Tumor tested and confirmed BRCA1/2 wild type at a qualified center
You will not qualify if you...
- Primary or secondary immune deficiency
- Any uncontrolled medical condition that increases risk during treatment
- Use of any other investigational drug within 30 days before randomization
- Second primary cancer except certain adequately treated cancers with no disease for 5 years
- Severe heart, lung, liver, or kidney failure
- Uncontrolled or active infection
- Legal incompetence, limited competence, or institutional detainment
- Prior pelvic or abdominal radiotherapy
- Mucinous adenocarcinoma or low grade carcinoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wu Xiaohua
Shanghai, Shanghai Municipality, China, 200023
Actively Recruiting
Research Team
Z
zhong zheng, dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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