New chemotherapy approach for advanced ovarian cancer
A Phase III,Randomized, Multi-center, Open Label Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in BRCA1/2 Wide-type Stage III and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
PHASE3 · Fudan University · NCT04520074
This study is testing a new three-step chemotherapy plan for women with advanced ovarian cancer to see if it can help keep the cancer from coming back after surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 590 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Fudan University (other) |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04520074 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates a novel three-step adjuvant chemotherapy regimen for women with BRCA1/2 wide-type ovarian cancer following optimal cytoreductive surgery. The regimen includes an initial treatment with paclitaxel and carboplatin, followed by two additional chemotherapy steps using etoposide and cyclophosphamide, aimed at reducing recurrence rates and prolonging the duration of treatment effectiveness. The study seeks to assess both the efficacy and safety of this approach compared to standard maintenance therapies. The trial is designed for patients diagnosed with advanced-stage ovarian cancer who have achieved complete remission after initial chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-75 with stage III/IV ovarian cancer who have undergone optimal cytoreductive surgery and achieved complete remission.
Not a fit: Patients with primary or secondary immune deficiencies or uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with advanced ovarian cancer.
How similar studies have performed: Previous observational studies have indicated potential success with similar chemotherapy approaches, although this specific regimen is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Wu Xiaohua — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: zhong zheng, dr
- Email: alizheng@126.com
- Phone: 862164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Cancer, adjuvent chemotherapy, ovarian cancer, maitainance therapy