NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.
- Registration Number
- NCT03752216
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 141
I-1 Female patients must be ≥ 18 years of age. I-2 Signed informed consent and ability to comply with treatment and follow-up. I-3 Patients with histologically proved high grade epithelial ovarian cancer or fallopian tube or primary peritoneal adenocarcioma.
I-4 Platine sensitive and ovarian, fallopian or peritoneal cancer recurrent patients with a complete response or partial response after a line of platine based chemotherapy.
I-5 Participant must have adequate organ function, defined as follows:
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 9 g/dL
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
- Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
- Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN I-6 Patients with an indication of maintenance by Niraparib after platine based chemotherapy according to the labelling (see appendix 17).
I-7 As this study will include patients in France, a subject will be eligible in this study only if either affiliated to, or a beneficiary of, a social category.
I-8 Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
I-9 Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
I-10 Participant must agree to not donate blood during the study or for 90 days after the last dose of Niraparib.
I-11 Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 1 month after the last dose of study treatment, or is of nonchildbearing potential.
I-12 Participant must agree to not breastfeed during the study or for 1 month after the last dose of Niraparib.
I-13 Participant must have normal blood pressure or adequately treated and controlled hypertension
E-1 Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
E-2 Participant must not be simultaneously enrolled in any interventional clinical trial.
E-3 Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
E-4 Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
E-5 Participant last treatment with platinum-based chemotherapy was ≥12 weeks from initiation of protocol therapy E-6 Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
E-7 Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks NiQoLe - Study protocol - v3.0 on 08/10/2020 Page 10 on 109 N° EudraCT: 2018-002274-44 prior to initiating protocol therapy. E-8 Participant must not have received colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. E-9 Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment. E-10 Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). E-11 Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. E-12 Participant must not be deprived of liberty, under guardianship or under trusteeship.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NIRAPARIB Niraparib Oral Niraparib Daily
- Primary Outcome Measures
Name Time Method Toxicities inducing dose modifications of Niraparib between the start to the cycle 3 (interruption, discontinuation and dose reduction). 3 months Evaluate treatment toxicities
- Secondary Outcome Measures
Name Time Method Duration of Niraparib treatment Up to 18 months. From the start of Niraparib until progression or unacceptable toxicity.
Self-reported symptoms and side effects with the NCI PRO-CTCAE Up to 18 months. Self-reported symptoms and side effects
Reasons of the dose modification of Niraparib Up to 18 months. Reasons of the dose modification of Niraparib
Self-reported fatigue by patient by FACT-F questionnaire (Functional Assessment of Cancer Therapy General - Fatigue) Up to 18 months. Functional Assessment of Cancer Therapy General Fatigue questionnaire (score range from 0 to 52 - Higher scores represent better quality of life)
Pain related to the treatment by Visual Analogic Scale (VAS) Up to 18 months. Score range from 0 \[worse outcome\] to 10 \[better outcome\])
Side effects of interest (HTA, anemia, thrombocytopenia) Up to 18 months. Side effects of interest (HTA, anemia, thrombocytopenia)
Initial cognitive functions by FACT-cog (Functional Assessment of Cancer Therapy - Cognitive Function) questionnaire At the inclusion visit FACT-cog questionnaire (score range from 0 to 132 - Higher scores represent better functioning)
Plasma level of Niraparib before Niraparib administration 3 months residual dosage of Niraparib
Geriatric Depression Scale (score range from 0 [better outcome] to 30 [worse outcome]) Up to 6 months. Geriatric Depression Scale (score range from 0 \[better outcome\] to 30 \[worse outcome\])
General health-related quality of life by FACT-G questionnaire (Functional Assessment of Cancer Therapy General) Up to 18 months. Functional Assessment of Cancer Therapy General questionnaire (score range from 0 \[worse outcome\] to 108 \[better outcome\])
Time to first subsequent line of anti-cancer therapy Up to 18 months. From the stop of Niraparib to the first subsequent line of anti-cancer therapy.
Overall response rate Up to 18 months. Overall response rate
Trial Locations
- Locations (30)
Centre Georges François Leclerc
🇫🇷Dijon, France
SASU Centre d'Oncologie et Radiothérapie 37
🇫🇷Chambray-lès-Tours, France
Groupe Hospitalier Mutualiste de Grenoble - Institut Daniel Hollard
🇫🇷Grenoble, France
Clinique Tivoli
🇫🇷Bordeaux, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
Centre Hospitalier Saint-Malo
🇫🇷Saint-Malo, France
Clinique Mutualiste de l'Estuaire
🇫🇷Saint-nazaire, France
Centre Hospitalier Régional d'Orléans
🇫🇷Orléans, France
Hôpital Cochin
🇫🇷Paris, France
Centre CARIO - HPCA
🇫🇷Plérin, France
Groupe Hospitalier Diaconesses-Croix Saint Simon
🇫🇷Paris, France
Institut du Cancer Courlancy
🇫🇷Reims, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Institut de Cancérologie de Lorraine
🇫🇷Vandœuvre-lès-Nancy, France
Sainte-Catherine Institut du Cancer Avignon-Provence
🇫🇷Avignon, France
CHRU Jean Minjoz
🇫🇷Besançon, France
Institut Bergonié
🇫🇷Bordeaux, France
Hôpital Fleyriat
🇫🇷Bourg-en-bresse, France
Centre François Baclesse
🇫🇷Caen, France
Medipole de Savoie
🇫🇷Challes-les-Eaux, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Les Hôpitaux de Chartres - Hôpital Louis Pasteur
🇫🇷Le Coudray, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
ICM Val d'Aurelle
🇫🇷Montpellier, France
Médipôle de NANCY / Centre d'Oncologie de Gentilly
🇫🇷Nancy, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Centre ONCOGARD - Institut de Cancérologie du Gard
🇫🇷Nimes, France
CHU de Saint-Etienne - Pôle de Cancérologie
🇫🇷Saint-Priest-en-Jarez, France
Hôpitaux Universitaires de Strasbourg - Institut de Cancérologie Strasbourg Europe
🇫🇷Strasbourg, France
Clinique Pasteur
🇫🇷Toulouse, France