Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer (RENI-1)

An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epithelial Ovarian Cancer
• Intervention / Treatment: Drug: Niraparib

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Lingying Wu; Phone Number: 010-87788996; Email: wulingying@csco.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed ovarian cancer

Description

Inclusion Criteria:

• Women aged 18 years or older
• Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma
• Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy
• Understand the protocol, and Written informed consent before any study-related procedure

Exclusion Criteria:

• Participating in other clinical trials at the same time
• Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators
• Having other malignant tumors (other than breast cancer with BRCA mutation)
• Pregnancy or breast feeding, or planning a pregnancy during the study
• Unable to visit on time
• Patients who are allergic to the study drug or drug components

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Starting dose of Niraparib	Record the starting dose of Niraparib in real clinical practice	up to 3 years
Percentage of patients who have taken dose adjustment and the reason of dose adjustment	Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment	up to 3 years
Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation	Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation	up to 3 years
Concomitant treatments which patients take along with Niraparib	Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all AEs	Incidence of all AEs based upon CTCAE version 5.0 during subjects receiving the study treatment.	up to 3 years
Progression-free survival (PFS)	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.	up to 3 years
Time to First Subsequent Therapy (TFST)	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.	up to 3 years
Chemotherapy-Free Interval (CFI)	CFI was defined as the time to the initiation of the next anti-cancer therapy after maintenance treatment.	up to 3 years
Overall Survival (OS)	Overall survival is defined as the date of the last day of previous chemotherapy to the date of death by any cause.	up to 3 years
Change From Baseline in EQ-5D-5L	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.	up to 3 years

Collaborators and Investigators

• Sponsor: Ling-Ying Wu

Study record dates

Study Major Dates

• Study Start (Anticipated): August 10, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): February 28, 2025

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Niraparib
• Other Study ID Numbers: 21/251-2922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No