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

Sponsor
ARCAGY/ GINECO GROUP (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05364905
Collaborator
Merck Sharp & Dohme LLC (Industry)
200
Enrollment
30
Locations
12
Anticipated Duration (Months)
6.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Patients Characteristics, Treatment Pattern & Outcomes of Patients With Advanced, Recurrent or Metastatic Endometrial Carcinoma: A Retrospective Study
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Clinical, biological and treatment characteristics [up to 3 years]

    Description of the data

Secondary Outcome Measures

  1. Progession Free Survival real world (rwPFS) [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

  2. Overall Survival (OS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Victor Dupouy Argenteuil France 95100
2 Sainte-Catherine Institut du Cancer Avignon-Provence Avignon France 84918
3 CHRU Besançon - Hôpital Jean Minjoz Besançon France 25000
4 Guillaume BABIN Bordeaux France 33000
5 Hôpital Morvan CHRU de Brest Brest France 29200
6 Centre d'Oncologie et de Radiothérapie 37 Chambray-lès-Tours France 37175
7 Hôpital Louis Mourier Colombes France 92700
8 Centre Hospitalier Intercommunal de Créteil Créteil France 21079
9 CHU de Dijon Dijon France 21000
10 Centre Georges François Leclerc Dijon France 21079
11 Groupe Hospitalier Mutualiste de Grenoble Grenoble France 38028
12 Centre Oscar Lambret Lille France 59020
13 Centre Léon Bérard Lyon France 69737
14 ICL - Centre Alexis Vautrin Nancy France 54000
15 ORACLE - Centre d'Oncologie de Gentilly Nancy France 54100
16 Hôpital Privé du Confluent Nantes France 44277
17 Centre Antoine Lacassagne Nice France 06189
18 Centre ONCOGARD - Institut de cancérologie du Gard Nîmes France 30029
19 CHR Orléans Orléans France 45100
20 Institut Curie Paris France 75005
21 Hôpital Cochin Paris France 75014
22 Hôpital Européen Georges Pompidou Paris France 75015
23 Groupe Hospitalier Diaconesses - Croix Saint-Simon Paris France 75020
24 Centre CARIO - HPCA Plérin France 22190
25 CHU de Poitiers - Hôpital de la Milétrie Poitiers France 86021
26 Centre Eugène Marquis Rennes France 35042
27 ICO - Centre René Gauducheau Saint-Herblain France 44805
28 ICANS - Institut de cancérologie Strasbourg Europe Strasbourg France 67033
29 CHU Tours - Hôpital Bretonneau Tours France 37044
30 Gustave Roussy Villejuif France 94805

Sponsors and Collaborators

  • ARCAGY/ GINECO GROUP
  • Merck Sharp & Dohme LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT05364905
Other Study ID Numbers:
  • GINECO-EN106
First Posted:
May 6, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Endometrial Neoplasms
Recurrence

Study Results

No Results Posted as of May 6, 2022