Neoadjuvant therapy for BRCA1-mutated ovarian cancer using cisplatin and mitomycin C
Efficacy of Neoadjuvant Therapy With Cisplatin Plus Mitomycin C in BRCA1-Mutated Ovarian Cancer
This study is testing a new combination of chemotherapy drugs for women with advanced BRCA1-mutated ovarian cancer to see if it works better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | N.N. Petrov National Medical Research Center of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St.-Petersburg, Pesochny-2, St.-Petersburg) |
| Trial ID | NCT04747717 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and efficacy of a neoadjuvant chemotherapy regimen combining mitomycin C and cisplatin in patients with BRCA1-mutated ovarian cancer, compared to the standard treatment of paclitaxel and carboplatin. Participants must have confirmed epithelial ovarian or fallopian tube carcinoma at advanced stages (IIB-IV) and carry BRCA1/BRCA2 mutations. The study involves random assignment to either the experimental or standard treatment arm, followed by assessment of treatment response and potential surgical intervention based on clinical outcomes. The trial aims to determine if the new regimen offers improved efficacy over the standard approach.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed advanced-stage epithelial ovarian or fallopian tube carcinoma who have BRCA1/BRCA2 germline mutations.
Not a fit: Patients with early-stage ovarian cancer or those with wild-type BRCA status may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective neoadjuvant therapy option for patients with BRCA1-mutated ovarian cancer.
How similar studies have performed: Other studies have shown promising results with neoadjuvant chemotherapy in ovarian cancer, but this specific combination is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically confirmed epithelial ovarian carcinoma or fallopian tubes carcinoma * FIGO stage IIB, IIC, III, or IV disease * BRCA1/BRCA2 germline mutation Exclusion Criteria: * WHO performance status \>3 * FIGO early stage * wt BRCA status * cytological verification
Where this trial is running
St.-Petersburg, Pesochny-2, St.-Petersburg
- NMRC of Oncology named after N.N.Petrov of MoH of Russia — St.-Petersburg, Pesochny-2, St.-Petersburg, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Igor Berlev
- Email: iberlev@gmail.com
- Phone: +79219612777
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.