An INternational Frontline Ovarian Cancer Real World Management Study

NCT04460768CompletedOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

AstraZeneca

Enrollment

989

Start Date

2020-06-27

Completion Date

2020-11-10

Study Type

OBSERVATIONAL

Official Title

A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study

Conditions

Ovarian Neoplasms

Eligibility

Sex

FEMALE

Inclusion Criteria:

* Female subjects above the age of 18
* Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous \[high or low grade\], mucinous, endometrioid, clear cell, mixed, and others) ovarian cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is available (not mandatory to be ovarian cancer related) as a proxy of healthcare use prior to the diagnosis of advanced-stage epithelial ovarian cancer

Exclusion Criteria:

* Patients being included in interventional clinical trials with PARPi for the treatment of advanced-stage high-grade epithelial ovarian cancer treatment during the study period
* Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
* Other malignancies within the past five years, except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. Patients with a history of localized breast cancer may have been eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and remained free of recurrent or metastatic disease

Outcome Measures

Primary Outcomes

Progression-free survival

In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Secondary Outcomes

Platinum free interval

The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Time to progression

The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Duration of treatment

The length of time from the start of anti-cancer treatment to end of anti-cancer treatment

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Time to first subsequent treatment

The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Overall survival

Duration from the index date to the date of death (if available)

Time frame: Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018

Locations

Research Site, Melbourne, Australia

Research Site, Seoul, South Korea

Research Site, New Taipei City, Taiwan

Research Site, Taipei, Taiwan