Clinical trial NCT04986371: Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
Official title: An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2021-08-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed ovarian cancer

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Starting dose of Niraparib
timeFrame: up to 3 years
measure: Percentage of patients who have taken dose adjustment and the reason of dose adjustment
timeFrame: up to 3 years
measure: Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
timeFrame: up to 3 years
measure: Concomitant treatments which patients take along with Niraparib
timeFrame: up to 3 years
Secondary outcomes:
measure: Incidence of all AEs
timeFrame: up to 3 years
measure: Progression-free survival (PFS)
timeFrame: up to 3 years
measure: Time to First Subsequent Therapy (TFST)
timeFrame: up to 3 years
measure: Chemotherapy-Free Interval (CFI)
timeFrame: up to 3 years
measure: Overall Survival (OS)
timeFrame: up to 3 years
measure: Change From Baseline in EQ-5D-5L
timeFrame: up to 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Lingying Wu
role: PRINCIPAL_INVESTIGATOR
References: