Brief Title
Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR
Official Title
Multi-Centre Observational Study of Maintenance Niraparib in Treatment of Ovarian CanceR: UK Routine Clinical Practice Experience
Brief Summary
This is a multi-centre, observational (non-interventional) study, designed to follow patients
with advanced ovarian fallopian tube and primary peritoneal cancer, who are receiving
Niraparib as maintenance treatment, according to the Niraparib access criteria (via TESARO
patient access programme, EMA licence and NHS pending NICE assessment due 2018) including
assessment of tolerability to Niraparib therapy.
Detailed Description
This is a multi-centre, observational (non-interventional) study, designed to follow patients
with advanced ovarian fallopian tube and primary peritoneal cancer, who are receiving
Niraparib as maintenance treatment, according to the Niraparib access criteria (via TESARO
patient access programme, EMA licence and NHS pending NICE assessment due 2018) including
assessment of tolerability to Niraparib therapy. These pathways will include patients who
have been registered and not prescribed drug. In these cases, the reason for patients not
receiving Niraparib will be recorded. Up to 15 centres will be involved in the study. Centres
will be selected based on interest in or experience of prescribing Niraparib and geographical
location in order to give a representative picture of the management of Niraparib in the UK.
Cohort 1: Retrospective Cohort
This cohort will include:
- Patients who have previously commenced maintenance Niraparib prior to the MONITOR study
opening at the site and are still receiving Niraparib but in whom quality of life data
are not available.
- Patients who have previously commenced Niraparib prior to the MONITOR Study opening at
the site but are now deceased but will be eligible for retrospective data collection
without the need for informed consent.
- Patients who have previously commenced maintenance Niraparib prior to the MONITOR study
opening at the site but have discontinued treatment.
- Data in respect of AEs, SAEs, ADRs and AESIs will be recorded in Case Report Forms and
be identified via the patient's medical records. There is no requirement to complete
trial specific SAE reporting forms in this cohort.
Cohort 2: Prospective Cohort
This cohort will include:
- Patients who have previously commenced maintenance Niraparib prior to the MONITOR study
opening at the site and are still receiving Niraparib and in whom quality of life data
is available.
- Patients who are due to commence maintenance Niraparib treatment.
The collection of QoL data, using EQ-5D-5L and EORTC QoL-OV28, FACT-O questionnaires will be
mandatory. For patients continuing on Niraparib, data will be collected retrospectively to
the point they sign the consent form, and prospectively. Going forward QoL data will not be
collected for these patients unless available as part of routine clinical care and baseline
QoL is available.
The collection of data relating to adverse events will be mandatory. The scope of adverse
events to be recorded includes AEs, SAEs, ADRs and AESIs - see section 5.3.1 for definitions
of these events. Details in respect of AEs and SAEs, ADRs and AESIs will be recorded during
routine clinic visits or via standard of care contact with the patient.
No additional visits will be required, no study medication will be administrated, and no
additional procedures will be performed outside the local routine practice as part of the
trial. Patients will be managed and followed up according to routine practice. Only data
available in the patient's medical record will be collected. Patients consented to cohort 2
will be asked to complete validated QoL tools; EQ-5D-5L, FACT-O and EORTC QOL-OV28.
Approximately 200 patients will be enrolled with an estimated 50 in the retrospective cohort
and 150 in the prospective cohort.
Study Type
Observational
Primary Outcome
Treatment Emergent Adverse Events
Secondary Outcome
Treatment history for patients on Niraparib maintenance treatment
Condition
Ovarian Cancer
Intervention
Niraparib
Study Arms / Comparison Groups
Cohort 1: Retrospective Cohort
Description: This cohort will include: Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site and are still receiving Niraparib but in whom quality of life data are not available. Patients who have previously commenced Niraparib prior to the MONITOR Study opening at the site but are now deceased but will be eligible for retrospective data collection without the need for informed consent. Patients who have previously commenced maintenance Niraparib prior to the MONITOR study opening at the site but have discontinued treatment. Data in respect of AEs, SAEs, ADRs and AESIs will be recorded in Case Report Forms and be identified via the patient's medical records. There is no requirement to complete trial specific SAE reporting forms in this cohort.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
200
Start Date
February 3, 2020
Completion Date
August 3, 2022
Primary Completion Date
February 3, 2022
Eligibility Criteria
Inclusion Criteria:
- Female patient 18 years old or over
- Patients who are planned to receive Niraparib for advanced ovarian fallopian tube or
primary peritoneal cancer,
- Patients who have previously commenced maintenance Niraparib prior to study opening at
site
- Deceased patients who have previously been prescribed Niraparib
- Patients able to give written informed consent, complete questionnaires in English and
comply with study procedures (if applicable).
Exclusion Criteria:
- • Patients aged <18 years old
- Patients unable to give informed consent, complete questionnaires in English or
comply with study procedures (if applicable).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Susana Banerjee, MBBS MA PhD FRCP, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04295577
Organization ID
CCR4939
Responsible Party
Sponsor
Study Sponsor
Royal Marsden NHS Foundation Trust
Study Sponsor
Susana Banerjee, MBBS MA PhD FRCP, Study Chair, Royal Marsden NHS Foundation Trust
Verification Date
March 2020