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Efficacy of Neoadjuvant Therapy With Cisplatin Plus Mitomycin C in BRCA1-Mutated Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT04747717
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
N.N. Petrov National Medical Research Center of Oncology

Study Description
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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)).

Condition or disease Intervention/treatment Phase
Ovarian Cancer Procedure: chemotherapy/surgery Not Applicable

Detailed Description:

The trial includes two arms, one of which is experimental arm with MP regimen chemotherapy that is compared with other arm with the standard TC regimen chemotherapy. To participate in this study, patients must have histologically confirmed epithelial ovarian carcinoma (ОС) or fallopian tubes carcinoma and FIGO stage IIB, IIC, III, or IV disease and BRCA1/BRCA2 germline mutation. All OC patients before the treatment start are subjected to the testing for BRCA1/BRCA2 mutations cases that are examined by the next-generation sequencing. All BRCA1/2 mutation carriers, who could not be treated by primary debulking surgery owing to extensive tumor spread, are given neoadjuvant chemotherapy. OC patients are randomly assigned to receive the TP regimen (paclitaxel at175 mg/m2 and carboplatin AUC5-6) or the MP regimen (mitomycin C at 10 mg/m2 and cisplatin at 100 mg/m2).

After 3-4 cycles of neoadjuvant chemotherapy, a formal assessment is made and patients are categorized according to the RECIST 1.1 standard. The patients who show partial clinical response or complete clinical response has to be undergoing interval debulking surgery. The patients who show stabilization of the process should continue chemotherapy for up to 6 cycles, followed by an assessment of the treatment (it is possible to continue up to 12 cycles) and a decision on whether to perform interval debulking surgery. Patients categorized as progressed clinically has to finish the protocol treatment and are allowed to receive any secondary treatment at the investigators' discretion. For those patients undergoing interval debulking surgery has to receive further regimens (up to 6 cycles of protocol treatment) without changing chemotherapy regimen. After six cycles of protocol treatment, the patients had to be categorized with regard to their final response status with the use of clinical/radiologic assessment. Patients not showing disease progression at this point could cease all cytotoxic therapy or can receive three additional cycles of protocol treatment.

While on protocol therapy, patients underwent the following procedures: symptom recording and physical examination every 3 weeks, complete blood cell counts weekly for the first two cycles and every 3 weeks thereafter, and laboratory tests of blood and CA 125 measurements on day 1 of each cycle.

Radiologic investigations to document the status of all measurable lesions noted at baseline had to be repeated after three, six, and nine cycles of chemotherapy. Once patients were off the protocol therapy, they were monitored for assessment of disease status every 3 months for 2 years and every 6 months thereafter. Monitoring comprised clinical examination and CA 125 estimation; routine computed tomography scans were not required but were requested if the CA 125 level rose and/or symptoms developed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Neoadjuvant Therapy With Cisplatin Plus Mitomycin C in BRCA1-Mutated Ovarian Cancer
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mitomycin C and cisplatin regimen
mitomycin C at 10 mg/m2 and cisplatin at 100 mg/m2
 Procedure: chemotherapy/surgery
NEO chemotherapy/interval debulking surgery/AD chemotherapy
Active Comparator: Paclitaxel and carboplatin regimen
paclitaxel at 175 mg/m2 and carboplatin AUC5-6
 Procedure: chemotherapy/surgery
NEO chemotherapy/interval debulking surgery/AD chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 4 months after FPFV ]
    To assess the objective response rate (OR) by RECIST v1.1 2. Pathologic response

  2. Pathomorphological response [ Time Frame: 4 months after FPFV ]
    Pathomorphological response will assess after surgery by Bohm scale

  3. Progression Free Survival [ Time Frame: 3 years ]
    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


Secondary Outcome Measures :
  1. Adverse events incidence [ Time Frame: Until 30 days after last patient treatment visit ]
    is defined as the interval between the date last chemotherapy cycle and the date of progression of the disease or death or start of a new therapy without evidence of progression, whichever occurred first


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747717


Contacts
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Contact: Igor Berlev +79219612777 iberlev@gmail.com
Contact: Tatyana Gorodnova +79213058218 t.gorodnova@mail.ru

Locations
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Russian Federation
NMRC of Oncology named after N.N.Petrov of MoH of Russia Recruiting
St.-Petersburg, Pesochny-2, St.-Petersburg, Russian Federation, 197758
Contact: Gorodnova Tatyana    8-921-305-82-18    t.gorodnova@mail.ru   
Sponsors and Collaborators
N.N. Petrov National Medical Research Center of Oncology
Investigators
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Study Chair: Igor Berlev National Medical Research Centre of Oncology named after N.N. Petrov
More Information
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Responsible Party: N.N. Petrov National Medical Research Center of Oncology
ClinicalTrials.gov Identifier: NCT04747717    
Other Study ID Numbers: OvCa-NeoMP
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by N.N. Petrov National Medical Research Center of Oncology:
Ovarian cancer
Neoadjuvant chemotherapy
Mitomycin C
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type