Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— RENI-1  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04986371
• Other study ID #: 21/251-2922
• Status: Not yet recruiting
• Start date: August 10, 2021
• Est. completion date: February 28, 2025

Study information

• Verified date: July 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Lingying Wu
• Phone: 010-87788996
• Email: wulingying[@]csco.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 28, 2025
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Niraparib
Usage following drug insert is recommended

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ling-Ying Wu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Starting dose of Niraparib	Record the starting dose of Niraparib in real clinical practice	up to 3 years
Primary	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
Primary	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
Primary	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	Incidence of all AEs	Incidence of all AEs based upon CTCAE version 5.0 during subjects receiving the study treatment.	up to 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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