Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study

ARCAGY/ GINECO GROUP30 sites in 1 country200 target enrollmentMay 9, 2022

ConditionsOncology Endometrial Cancer Advanced Cancer Recurrent Cancer Metastatic Cancer

InterventionsChemotherapy

DrugsChemotherapy

Overview

Phase: Not Applicable
Intervention: Chemotherapy
Conditions: Oncology
Sponsor: ARCAGY/ GINECO GROUP
Enrollment: 200
Locations: 30
Primary Endpoint: Clinical, biological and treatment characteristics
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a national observational retrospective multi-site chart review study of patients with advanced, recurrent or metastatic endometrial carcinoma.

Registry

clinicaltrials.gov

Start Date

May 9, 2022

End Date

November 22, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

ARCAGY/ GINECO GROUP

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult women ≥ 18 years at index date.
•Documented diagnosis of advanced recurrent or metastatic endometrial cancer not eligible to primary complete surgery. Patients with interval surgery after primary CT may be eligible.
•Index date should represent at least the first\* or second line\*\* chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December
•do not express refusal to her personal data processing or did not express her refusal for deceased patients.

Exclusion Criteria

•No clinical records for tumor imaging or administration of anti-cancer therapy.
•Patients with active malignancy other than EC cancer which contribute significantly to the clinical impairment of the patient during the study period, according to investigator opinion.
•Patients lost to follow-up, defined as patients whose last follow-up information occurs less than two years after index date (unless the patient is deceased).
•Patient did not receive chemotherapy systemic treatment.
•Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.

Arms & Interventions

Cohort 1

Patients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019

Intervention: Chemotherapy

Cohort 2

Patients in second line treatment (after one prior systemic chemotherapy) in 2019

Intervention: Chemotherapy

Outcomes

Primary Outcomes

Clinical, biological and treatment characteristics

Time Frame: up to 3 years

Description of the data

Secondary Outcomes

Overall Survival (OS)(through study completion, an average of 1 year)
Progession Free Survival real world (rwPFS)(through study completion, an average of 1 year)