This is a longitudinal, national, open, multi-centre phase IV study which will recruit up to 141 patients with ovarian cancer in late relapse treated with niraparib according to the labelling In France.
The aim of NiQoLe, phase IV study is to evaluate tolerability of Niraparib and the management by the physicians of the side-effects in real life in France. The study will also generate complementary data of NOVA trial on longitudinal follow up of closed symptoms and side effects reported by the patients especially with the NCI PRO (Patient-Reported Outcome)-CTCAE system. Specific oncogeriatric data will be collected among on a subgroup of elderly patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
141
Two different doses of Niraparib can be administrated: For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules. For patient who had at baseline (T0) a body weight \< 77 kg or a platelet count \<150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules. Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria.
Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction).
Evaluate treatment toxicities
Time frame: 3 months
Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue)
Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)
Time frame: Up to 18 months.
Self-reported symptoms and side effects with the NCI PRO-CTCAE
Self-reported symptoms and side effects
Time frame: Up to 18 months.
Reasons of the dose modification of Niraparib
Reasons of the dose modification of Niraparib
Time frame: Up to 18 months.
General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General)
Functional Assessment of Cancer Therapy General questionnaire (score range from 0 \[worse outcome\] to 108 \[better outcome\])
Time frame: Up to 18 months.
Pain related to the treatment by Visual Analogic Scale (VAS)
Score range from 0 \[worse outcome\] to 10 \[better outcome\])
Time frame: Up to 18 months.
Side effects of interest (HTA, anemia, thrombocytopenia)
Side effects of interest (HTA, anemia, thrombocytopenia)
Time frame: Up to 18 months.
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Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHRU Jean Minjoz
Besançon, France
Clinique Tivoli
Bordeaux, France
Institut Bergonié
Bordeaux, France
Hôpital Fleyriat
Bourg-en-Bresse, France
Centre François Baclesse
Caen, France
Medipole de Savoie
Challes-les-Eaux, France
SASU Centre d'Oncologie et Radiothérapie 37
Chambray-lès-Tours, France
Centre Jean Perrin
Clermont-Ferrand, France
...and 20 more locations
Duration of Niraparib treatment
From the start of Niraparib until progression or unacceptable toxicity.
Time frame: Up to 18 months.
Time to first subsequent line of anti-cancer therapy
From the stop of Niraparib to the first subsequent line of anti-cancer therapy.
Time frame: Up to 18 months.
Overall response rate
Overall response rate
Time frame: Up to 18 months.
Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire
FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)
Time frame: At the inclusion visit
Plasma level of Niraparib before Niraparib administration
residual dosage of Niraparib
Time frame: Day 8
Plasma level of Niraparib before Niraparib administration
residual dosage of Niraparib
Time frame: 3 months
Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome])
Geriatric Depression Scale (score range from 0 \[better outcome\] to 30 \[worse outcome\])
Time frame: Up to 6 months.