NCT04747717

Brief Summary

This study was designed to assess the safety and efficacy of neoadjuvant therapy with mitomycin C plus cisplatin (MP) in BRCA1-mutated ovarian cancer versus standard regimen (paclitaxel plus carboplatin (TP)).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable ovarian-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 11, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 29, 2021

Last Update Submit

February 10, 2021

Conditions

Ovarian Cancer

Keywords

Ovarian cancerNeoadjuvant chemotherapyMitomycin C

Outcome Measures

Primary Outcomes (3)

  • Response rate

    To assess the objective response rate (OR) by RECIST v1.1 2. Pathologic response

    4 months after FPFV

  • Pathomorphological response

    Pathomorphological response will assess after surgery by Bohm scale

    4 months after FPFV

  • Progression Free Survival

    As per RECIST v1.1. progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause

    3 years

Secondary Outcomes (1)

  • Adverse events incidence

    Until 30 days after last patient treatment visit

Study Arms (2)

Mitomycin C and cisplatin regimen

EXPERIMENTAL

mitomycin C at 10 mg/m2 and cisplatin at 100 mg/m2

Procedure: chemotherapy/surgery

Paclitaxel and carboplatin regimen

ACTIVE COMPARATOR

paclitaxel at 175 mg/m2 and carboplatin AUC5-6

Procedure: chemotherapy/surgery

Interventions

chemotherapy/surgeryPROCEDURE

NEO chemotherapy/interval debulking surgery/AD chemotherapy

Mitomycin C and cisplatin regimenPaclitaxel and carboplatin regimen

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed epithelial ovarian carcinoma or fallopian tubes carcinoma
  • FIGO stage IIB, IIC, III, or IV disease
  • BRCA1/BRCA2 germline mutation

You may not qualify if:

  • WHO performance status \>3
  • FIGO early stage
  • wt BRCA status
  • cytological verification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMRC of Oncology named after N.N.Petrov of MoH of Russia

Saint Petersburg, Pesochny-2, St.-Petersburg, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Drug TherapySurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Igor Berlev

    National Medical Research Centre of Oncology named after N.N. Petrov

    STUDY CHAIR

Central Study Contacts

Igor Berlev

CONTACT

+79219612777iberlev@gmail.com

Tatyana Gorodnova

CONTACT

+79213058218t.gorodnova@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 10, 2021

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

October 1, 2025

Last Updated

February 11, 2021

Record last verified: 2021-01

Locations

RU(1)