- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04573933
Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019. (BREIZH-PARPi)
Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019. Study of Efficacy and Safety Based on Finisterian Data Compared to Data in the Literature.
Study Overview
Status
Conditions
Detailed Description
Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers and 5th for mortality (4,720 new cases in France in 2017, for 3,111 deaths), and its origin is still imperfectly known. Several risk factors have been identified, the main ones being genetic (importance of heredity, BRCA mutations) and environmental (taking hormone replacement therapy based on estrogen at menopause, exposure to tobacco, asbestos…). Epithelial tumors are the most frequent (85%), with different subtypes: serous (40 to 50%); endometrioid (20%); mucinous (15%); clear cell (5%); or with transitional, undifferentiated and mixed cells. The classification used in clinical practice is the TNM classification which establishes the stage of the disease (FIGO). Initial treatment is based on surgery and chemotherapy. The standard scheme combines CARBOPLATIN and PACLITAXEL for 6 cycles. For advanced stages, IIIB, IIIC and IV, BEVACIZUMAB can be administered every 3 weeks in combination with CARBOPLATIN and PACLITAXEL, and is then continued as monotherapy for 15 months The management of recurrences depends on their time of occurrence. Before 6 months, it is a resistance to platinum, a monochemotherapy without platinum is then indicated, associated with BEVACIZUMAB, if it was not given initially and in the absence of contraindication. After 6 months, polychemotherapy with platinum must be administered, possibly associated with BEVACIZUMAB, again if it was not given initially and in the absence of a contraindication. This treatment is then continued after stopping chemotherapy, until progression or toxicity .The arrival of PARP (Poly-ADP-Ribose-Polymerase) inhibitors, such as OLAPARIB, NIRAPARIB, or even RUCAPARIB, has considerably modified the treatment regimen of these relapses known as "platinum-sensitive" These molecules act on the DNA repair system, in synergy with the loss of BRCA function by tumor cells, causing significant genetic instability leading to cell death. This is the principle of synthetic lethality. These treatments will also in the very near future modify the management of patients with ovarian cancer as soon as they are managed. In fact, the SOLO 1 study published in 2018 showed the benefit of OLAPARIB prescribed as maintenance treatment in BRCA mutated patients, in complete or partial response after chemotherapy based on platinum The PRIMA and VELIA studies, published in 2019, have shown the effectiveness of NIRAPARIB and VELIPARIB respectively, prescribed as maintenance therapy, regardless of the patients' BRCA status.The benefit of the treatment was greater in the group of patients with a defect in homologous recombination. Finally, the PAOLA study published in 2019, showed the benefit of OLAPARIB versus placebo, in combination with BEVACIZUMAB, as maintenance treatment in patients with ovarian cancer in full or partial response after chemotherapy with PLATINUM-PACLITAXEL-BEVACIZUMAB, regardless of their BRCA status PARP inhibitors are effective in maintenance to prevent the risk of relapse, in patients with recurrent ovarian cancer sensitive to platinum (relapse> 6 months after the last course of platinum), as proved by recent data from the medical literature. On the one hand, the SOLO 2 study showed an improvement in progression-free survival in patients with a BRCA constitutional or somatic mutation, in relapse of platinum-sensitive ovarian cancer, treated with OLAPARIB in maintenance (19.1 months versus 5.5 months) On the other hand, the NOVA (2016) and ARIEL 3 (2017) studies showed an improvement in progression-free survival in relapsed patients with platinum-sensitive ovarian cancer, treated with maintenance by NIRAPARIB or by RUCAPARIB respectively, regardless of their mutational status for BRCA (probable action on other homologous recombination pathways than BRCA, still unknown to date) All these molecules are now part of our therapeutic arsenal, from the 2nd line of treatment.
In this context of major progress in the management of ovarian cancer, we decided to set up a Finistère study, aiming to analyze the characteristics and survival data of patients treated with PARP inhibitor for a recurrent platinum-sensitive ovarian cancer, as well as their tolerance to these treatments. This is a retrospective study, using data from Finistère in comparison with data from the literature. Nevertheless, there may be a difference between "real life" and clinical trial data. Thus, the objective of this cohort is to assess whether the efficacy (survival) and safety (side effects) of PARP inhibitors is the same in Finistère patients as in the scientific literature.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brest, France, 29200
- Clinique Pasteur
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Brest, France, 29229
- Clinique Pasteur
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Morlaix, France, 29672
- CH des Pays de Morlaix
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Quimper, France, 29000
- CHIC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ≥ 18 years old
- High grade serous or clear cell ovarian cancer or endometrioid, including primary peritoneal cancer and fallopian tubes
- Treatment with PARP inhibitor (OLAPARIB, NIRAPARIB) in maintenance after sensitive platinum relapse
- No objection made
Exclusion Criteria:
- - Patients under judicial protection (guardianship)
- Refusal to participate
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: Through study completion, assessed up to 80 months
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Time from date of start of parp inhibitor therapy to date of first documented progression
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Through study completion, assessed up to 80 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
- Overall survival
Time Frame: Through study completion, assessed up to 80 months
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Time from date of start of parp inhibitor therapy to date of death of any cause
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Through study completion, assessed up to 80 months
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Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: through study completion, an average of 1 year
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% of patient with a grade ≥1 adverse event during treatment, according to CTCAE
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through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- BREIZH-PARPi (29BRC20.0092)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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