Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma (ENDOVIE)

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Argenteuil, France, 95100
        • Centre Hospitalier Victor Dupouy
      • Avignon, France, 84918
        • Sainte-Catherine Institut du Cancer Avignon-Provence
      • Besançon, France, 25000
        • CHRU Besancon - Hopital Jean Minjoz
      • Bordeaux, France, 33000
        • Guillaume BABIN
      • Brest, France, 29200
        • Hôpital Morvan CHRU de Brest
      • Chambray-lès-Tours, France, 37175
        • Centre d'Oncologie et de Radiothérapie 37
      • Colombes, France, 92700
        • Hopital Louis Mourier
      • Créteil, France, 21079
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France, 21079
        • Centre Georges François Leclerc
      • Dijon, France, 21000
        • Chu de Dijon
      • Grenoble, France, 38028
        • Groupe hospitalier mutualiste de Grenoble
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69737
        • Centre Leon Berard
      • Nancy, France, 54000
        • ICL - Centre Alexis Vautrin
      • Nancy, France, 54100
        • ORACLE - Centre d'Oncologie de Gentilly
      • Nantes, France, 44277
        • Hôpital Privé du Confluent
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nîmes, France, 30029
        • Centre ONCOGARD - Institut de cancérologie du Gard
      • Orléans, France, 45100
        • CHR Orléans
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75014
        • Hopital Cochin
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75020
        • Groupe Hospitalier Diaconesses - Croix Saint-Simon
      • Plérin, France, 22190
        • Centre CARIO - HPCA
      • Poitiers, France, 86021
        • CHU de Poitiers - Hôpital de La Milétrie
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Saint-Herblain, France, 44805
        • ICO - Centre René Gauducheau
      • Strasbourg, France, 67033
        • ICANS - Institut de cancérologie Strasbourg Europe
      • Tours, France, 37044
        • CHU Tours - Hôpital Bretonneau
      • Villejuif, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population musy respect all the inclusion and exclusion criteria.

Description

Inclusion Criteria:

  1. Adult women ≥ 18 years at index date.
  2. 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.
  3. Index date should represent at least the first* or second line** chemotherapy systemic treatment and occur between, 1, January 2019 and 31, December 2019.
  4. do not express refusal to her personal data processing or did not express her refusal for deceased patients.

Exclusion Criteria:

  1. No clinical records for tumor imaging or administration of anti-cancer therapy.
  2. 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.
  3. 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).
  4. Patient did not receive chemotherapy systemic treatment.
  5. Patient undergo treatment by pembrolizumab or another immunotherapy in first line (cohort 1) or second line (cohort 2) during the eligibity (inclusion) period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Patients in first line treatment (first chemotherapy for advanced, recurrent or metastatic endometrial cancer) in 2019
Drug: Chemotherapy
Patients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy.
Cohort 2
Patients in second line treatment (after one prior systemic chemotherapy) in 2019
Drug: Chemotherapy
Patients with confirmed advanced, recurrent or metastatic endometrial cancer, treated by chemotherapy in real life-setting, between 1st January 2019 to 31rd December March 2019, in first or second line of chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical, biological and treatment characteristics
Time Frame: up to 3 years
Description of the data
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progession Free Survival real world (rwPFS)
Time Frame: through study completion, an average of 1 year
From the date of initiation of the treatment in the corresponding line to the date of progression or death
through study completion, an average of 1 year
Overall Survival (OS)
Time Frame: through study completion, an average of 1 year
From the date of initiation of the treatment in the corresponding line to the date of death
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCAGY/ GINECO GROUP

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2022

Primary Completion (Actual)

November 22, 2022

Study Completion (Actual)

November 22, 2022

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

May 4, 2022

First Posted (Actual)

May 6, 2022

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GINECO-EN106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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