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

Endometrial Cancer Clinical Trial

— ENDOVIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05364905
• Other study ID #: GINECO-EN106
• Status: Completed
• Start date: May 9, 2022
• Est. completion date: November 22, 2022

Study information

• Verified date: September 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 22, 2022
• Est. primary completion date: November 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Metastatic Cancer
• Oncology
• Recurrence
• Recurrent Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Sainte-Catherine Institut du Cancer Avignon-Provence	Avignon
France	CHRU Besançon - Hôpital Jean Minjoz	Besançon
France	Guillaume BABIN	Bordeaux
France	Hôpital Morvan CHRU de Brest	Brest
France	Centre d'Oncologie et de Radiothérapie 37	Chambray-lès-Tours
France	Hôpital Louis Mourier	Colombes
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Centre Georges François Leclerc	Dijon
France	CHU de Dijon	Dijon
France	Groupe Hospitalier Mutualiste de Grenoble	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	ICL - Centre Alexis Vautrin	Nancy
France	ORACLE - Centre d'Oncologie de Gentilly	Nancy
France	Hôpital Privé du Confluent	Nantes
France	Centre Antoine Lacassagne	Nice
France	Centre ONCOGARD - Institut de cancérologie du Gard	Nîmes
France	CHR Orléans	Orléans
France	Groupe Hospitalier Diaconesses - Croix Saint-Simon	Paris
France	Hôpital Cochin	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Curie	Paris
France	Centre CARIO - HPCA	Plérin
France	CHU de Poitiers - Hôpital de la Milétrie	Poitiers
France	Centre Eugène Marquis	Rennes
France	ICO - Centre René Gauducheau	Saint-Herblain
France	ICANS - Institut de cancérologie Strasbourg Europe	Strasbourg
France	CHU Tours - Hôpital Bretonneau	Tours
France	Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical, biological and treatment characteristics	Description of the data	up to 3 years
Secondary	Progession Free Survival real world (rwPFS)	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
Secondary	Overall Survival (OS)	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