RENI-1: Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
Study Details
Study Description
Brief Summary
This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
In this study, 300 patients will be enrolled. Eligible patients will be those with histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma. Patients must have received one line of platinum-based chemotherapy, and be in clinically complete or partial response following the platinum-based chemotherapy prior to enrollment in the study. Patients will be treated with Niraparib according to the physician's judgement till disease progression, discontinuation for other reasons or death. The primary endpoint is treatment pattern of Niraparib as first-line maintenance treatment for ovarian cancer patients. The second endpoints include AE, PFS and quality of life.
Study Design
Outcome Measures
Primary Outcome Measures
- Starting dose of Niraparib [up to 3 years]
Record the starting dose of Niraparib in real clinical practice
- Percentage of patients who have taken dose adjustment and the reason of dose adjustment [up to 3 years]
Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment
- Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation [up to 3 years]
Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
- Concomitant treatments which patients take along with Niraparib [up to 3 years]
Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib
Secondary Outcome Measures
- Incidence of all AEs [up to 3 years]
Incidence of all AEs based upon CTCAE version 5.0 during subjects receiving the study treatment.
- Progression-free survival (PFS) [up to 3 years]
Progression-free survival is defined as the time from the last day of previous chemotherapy to first documentation of tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression.
- Time to First Subsequent Therapy (TFST) [up to 3 years]
The TFST was defined as the time from the last day of previous chemotherapy to the start date of the first subsequent anti-cancer therapy or death.
- Chemotherapy-Free Interval (CFI) [up to 3 years]
CFI was defined as the time to the initiation of the next anti-cancer therapy after maintenance treatment.
- Overall Survival (OS) [up to 3 years]
Overall survival is defined as the date of the last day of previous chemotherapy to the date of death by any cause.
- Change From Baseline in EQ-5D-5L [up to 3 years]
EQ-5D-5L is a well-validated, general preference-based, health-related QoL instrument. The EQ-5D-5L encompasses 5 domains, asking patients to rate their perceived health state today on the following dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 possible levels: "no problems" (Level 1), "slight problems" (Level 2), "moderate problems" (Level 3), "severe problems" (Level 4), and "extreme problems" (Level 5). Each domain is assigned a level, and levels are combined to create a 5-digit number describing the patient's health state. For each patient, an index value is determined from a published country-specific value set. This index value or utility score ranges from 0 to 1.00 (with 1.0 representing perfect health) and is used in the calculation of quality-adjusted life years (QALYs) that are used to inform economic valuations of health interventions. A positive change from baseline indicates improvement.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women aged 18 years or older
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Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
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Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
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Understand the protocol, and Written informed consent before any study-related procedure
Exclusion Criteria:
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Participating in other clinical trials at the same time
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Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
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Having other malignant tumors (other than breast cancer with BRCA mutation)
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Pregnancy or breast feeding, or planning a pregnancy during the study
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Unable to visit on time
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Patients who are allergic to the study drug or drug components
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ling-Ying Wu
Investigators
- Principal Investigator: Lingying Wu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/251-2922