NCT04520074 Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
| NCT ID | NCT04520074 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 590 participants |
| Start Date | 2021-10-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 590 participants in total. It began in 2021-10-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04520074 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04520074 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 590 participants.
Is NCT04520074 currently recruiting?
Yes, NCT04520074 is actively recruiting participants. Contact the research team at alizheng@126.com for enrollment information.
Where is the NCT04520074 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04520074 clinical trial?
NCT04520074 is sponsored by Fudan University. The trial plans to enroll 590 participants.
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