Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
Recruiting now · Phase 3
Conditions studied: Ovarian Cancer
In brief
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.
Key facts
- Study ID
- NCT04520074
- Run by
- Fudan University
- People needed
- 590
- Starts
- 2021-10-08
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2022-07-27
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Wu Xiaohua — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.