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Ovarian NeoplasmBREIZH-PARPiNCT04573933

Survival Data and Characteristics of Finisterian Patients Treated With PARP Inhibitors for Ovarian Cancer Between 2014 and 2019.

An observational study of Ovarian Neoplasm, run by University Hospital, Brest at 4 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasm
How many people
54 participants
Where
4 sitesFrance
Study dates
29 Jun 2020to 29 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who started treatment with PARP inhibitors on maintenance, between January 1, 2014 and December 31, 2019, for recurrent platinum-sensitive ovarian cancer

Who may be able to join

  • ≥ 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

Who cannot join

  • - Patients under judicial protection (guardianship)
  • Refusal to participate

Trial locations and contacts

4 sites in 1 country.

France4 sites
  • Clinique Pasteur

    Brest, 29200

  • Clinique Pasteur

    Brest, 29229

  • CH des pays de Morlaix

    Morlaix, 29672

  • CHIC

    Quimper, 29000

Other trials in France

About this study

Official title: 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.

Ovarian cancer is a relatively uncommon but serious disease. It ranks 10th for female cancers, 5th for mortality, and its origin is still imperfectly known. It has a silent history for a long time, is often diagnosed late, and the prognosis is poor with a high relapse rate. It is therefore necessary to assess and prevent the risk of relapse, in order to establish a diagnosis as early as possible, and thus set up the appropriate treatment. Poly-ADP-Ribose Polymerase (PARP) inhibitors such as OLAPARIB and NIRAPARIB are effective in maintenance to prevent the risk of relapse in patients with recurrent platinum-sensitive ovarian cancer, as proved by recent data from the medical 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 and safety of PARP inhibitors is the same in Finistère patients as in the scientific literature.

Read the 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.

Keywords
recurrent platinum-sensitive ovarian cancer ;, PARP inhibitors ;, Efficacy ;, Safety ;, Finisterian data
Medical subject headings
Ovarian Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Time from date of start of parp inhibitor therapy to date of first documented progression

    Measured: Through study completion, assessed up to 80 months

Secondary outcomes (2)
  1. - Overall survival

    Time from date of start of parp inhibitor therapy to date of death of any cause

    Measured: Through study completion, assessed up to 80 months

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    % of patient with a grade ≥1 adverse event during treatment, according to CTCAE

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start29 Jun 2020
  3. Primary completion29 Jul 2020
  4. Study completion29 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04573933
Sponsor's protocol ID
BREIZH-PARPi (29BRC20.0092)
Acronym
BREIZH-PARPi
Status last verified
Sep 2020
First submitted
21 Sep 2020
Last updated
5 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Neoplasm, run by University Hospital, Brest at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: Through study completion, assessed up to 80 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.

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