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Epithelial Ovarian CancerRENI-1NCT04986371

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

An observational study of Epithelial Ovarian Cancer, run by Ling-Ying Wu.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Epithelial Ovarian Cancer
What is being tested?
Niraparib
How many people
300 participants
Where
No sites listed yet
Study dates
10 Aug 2021to 28 Feb 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with newly diagnosed ovarian cancer

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Lingying Wu contact

010-87788996

wulingying@csco.org.cn

About this study

Official title: 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.

Read the 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.

Being tested
Niraparib
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called Zejula

    Usage following drug insert is recommended

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Starting dose of Niraparib

    Record the starting dose of Niraparib in real clinical practice

    Measured: up to 3 years

  2. 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

    Measured: up to 3 years

  3. 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

    Measured: up to 3 years

  4. Concomitant treatments which patients take along with Niraparib

    Record the concomitant treatments (drugs, or other tumor treatments) which patients take along with Niraparib

    Measured: up to 3 years

Secondary outcomes (6)

  1. Incidence of all AEs

    Incidence of all AEs based upon CTCAE version 5.0 during subjects receiving the study treatment.

    Measured: up to 3 years

  2. 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.

    Measured: up to 3 years

  3. 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.

    Measured: up to 3 years

  4. Chemotherapy-Free Interval (CFI)

    CFI was defined as the time to the initiation of the next anti-cancer therapy after maintenance treatment.

    Measured: up to 3 years

  5. 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.

    Measured: up to 3 years

  6. 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.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2021
  2. Study start10 Aug 2021 (estimated)
  3. Primary completion31 Aug 2022 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986371
Sponsor's protocol ID
21/251-2922
Acronym
RENI-1
Status last verified
Jul 2021
First submitted
16 Jul 2021
Last updated
2 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Epithelial Ovarian Cancer, run by Ling-Ying Wu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lingying Wu (010-87788996, wulingying@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Starting dose of Niraparib (time frame: up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986371.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.

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