Clinical trial NCT04295577: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: Niraparib
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced ovarian fallopian tube and primary peritoneal cancer, who are/have/ will be receiving Niraparib as maintenance treatment

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 16 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 350 patients will be enrolled with an estimated 100 in the retrospective cohort and 250 in the prospective cohort.

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).

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: February 2020 - August 2022
Secondary outcomes:
measure: Treatment history for patients on Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
measure: Patient demographics for patients on Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
measure: Medical history for patients on Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
measure: Routine clinical practice of Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
measure: Time to First Subsequent Therapy (TFST)
timeFrame: February 2020 - February 2024
measure: Chemotherapy Free Interval (CFI)
timeFrame: February 2020 - February 2024
measure: Objective Response Rate (ORR)
timeFrame: February 2020 - February 2024
measure: Progression Free Survival (PFS)
timeFrame: January 2022 - February 2024
measure: Quality of life for patients on Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
measure: Adverse events for patients on Niraparib maintenance treatment
timeFrame: February 2020 - February 2024
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath
city: Belfast
country: United Kingdom
facility: Belfast Health & Social Care Trust
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre, Velindre University NHS Trust
city: Lancaster
country: United Kingdom
facility: Morecambe Bay NHS Trust
city: Leeds
country: United Kingdom
facility: St James's University Hospital
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospital NHS Trust
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre, East and North Hertfordshire NHS Trust
city: Romford
country: United Kingdom
facility: Queen's Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Susana Banerjee, MBBS MA PhD FRCP
role: STUDY_CHAIR
References: