BRCA 1/2 Status as a Predictive Factor to Response to Platinum Based Chemotherapy in Cancer Ovary

March 11, 2024 updated by: Nesreen Haidra Ahmed Garad, Assiut University
The main objective of this prospective study is to assess the clinical outcomes of platinum based chemotherapy cases either cisplatin or carboplatin according to BRCA status in neoadjuvant and recurrent ovarian cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ovarian cancer was the third most common gynecological cancer globally in 2020. Ovarian carcinoma is the most common type of ovarian cancer, comprising over 90% of all ovarian cancer cases.

It is the most lethal gynecologic malignancy in high-income countries.

Approximately, 10-15% of epithelial ovarian cancer (EOC) patients carry germline mutation in BRCA1 or BRCA2. But,the majority of cases are sporadic.

Increased body mass index (BMI) and hormone replacement therapy (HRT) have been proposed as major contributors along with smoking and occupational hazards e.g., asbestos exposure.

Studies have reported that the prevalence of BRCA mutations varies among different epithelial ovarian ca ( EOC) subtypes, with prevalence of 20%-25% reported for the high-grade serous subtype , BRCA mutations were reported in <10% of the endometrioid subtype and with very low frequency in clear cell subtype (6.3%).

The absence of BRCA1/2 function is associated with a cumulative lifetime risk for developing epithelial ovarian cancer of 40% to 50% in patients who are BRCA1-mutation carriers and 20% to 25% in patients who are BRCA2-mutation carriers.

Improved prognosis in terms of progression-free survival (PFS) and overall survival (OS), with higher partial response (PR) and complete response (CR) rates to platinum-containing regimens and longer treatment-free intervals, has been observed in retrospective studies of patients who are BRCA1/2-mutant carriers with ovarian cancer compared with patients who are non.

However, despite a generally favorable response to first-line chemotherapy, the disease frequently recurs. Due to limited therapeutic options, sequential chemotherapy regimens are often used based on platinum sensitivity (determined by the platinum-free interval), residual toxicities, general condition/performance status, and co-morbidities, with suboptimal outcomes and cumulative toxicity. Treatment effectiveness decreases over time, with resistance to platinum drugs precluding diminished survival and quality of life.

Germ-line BRCA mutations are associated with longer survival rates after ovarian cancer diagnosis and generally favorable response to platin-based therapy.

No data available for recurrent cases to assess the response of platinum based chemotherapy in BRCA mutant or wild cases.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Ovarian cancer patients

Description

Inclusion Criteria:

  • Age above 18 years,
  • Pathologically proven ovarian cancer,epithelial origin.
  • BRCA mutant/wild
  • Recurrent cases who are eligible to anti-VEGF (Bevacizumab).
  • Patients with clinical stages T1-T3c , N0-N1b, M0, and recurrent platinum sensitive cases.
  • Patients with good renal and liver functions.
  • No other malignancy (double malignancy).
  • Performance status 0-2 according to ECOG performance status scale.

Exclusion Criteria:

  • Performance status 3-4 according to ECOG performance status scale.
  • Patients refuse to receive chemotherapy,
  • Patients not eligible to receive chemotherapy due to liver or renal impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate.
Time Frame: 1 year
percentage of people in the study or treatment group who have a partial response or complete response to the treatment within a certain period of time; wil be correlated with BRCA status.
1 year
Progression free survival
Time Frame: 1 year
the time from starting the study till disease progression or death from any cause
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival and toxicity
Time Frame: 2 years
the length of time from either the date of diagnosis or start of treatment for cancer ovary are still alive
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • BRCA 1/2 in cancer ovary

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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