Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
EndoQOL
1 other identifier
interventional
51
1 country
5
Brief Summary
Through this study, The investigator believe to evaluate the impact in terms of overall quality of life of adjuvant chemotherapy in patients with locally advanced endometrial cancer at a distance from their care
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedStudy Start
First participant enrolled
March 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2020
CompletedResults Posted
Study results publicly available
December 18, 2025
CompletedDecember 18, 2025
December 1, 2025
12 months
February 27, 2018
October 3, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire
The Quality of life questionnaire (QLQ-C30) contains 29 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many clinical trials in oncology. Here is the glodal health status scale of the QLQ-C30 questionnaire, ranging from 0 to 100, with high score indicating good quality of life.
2 years after chemotherapy
Secondary Outcomes (2)
Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire
2 years after chemotherapy
Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire
2 years after chemotherapy
Other Outcomes (2)
Anxiety by the HADS Questionnaire
2 years after chemotherapy
Depression by the HADS Questionnaire
2 years after chemotherapy
Study Arms (2)
Patients treated with chemotherapy
OTHERPatients not treated with chemotherapy
OTHERInterventions
Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)
Eligibility Criteria
You may qualify if:
- For all patients:
- Women over 18 years of age, with histologically confirmed histologic type 1 or type 2 endometrial adenocarcinoma, with FIGO postoperative II or III stage operated between 2011 and 2015, with at least 2 years of follow-up compared to the last course of chemotherapy;
- Recommended surgery such as hysterectomy and bilateral salpingo-oophorectomy, non-mandatory surgical nodal staging;
- Pelvic radiotherapy +/- lumbar-aortic irradiation, optional brachytherapy;
- No recurrence of endometrial cancer at baseline;
- Absence of evolutionary neurological antecedent (multiple sclerosis, neurodegenerative pathology ...);
- Absence of progressive psychiatric pathology (i.e. psychiatric hospitalization, bipolar disorder, schizophrenia, personality disorders ...);
- No opposition to the collection of data;
- Patient deemed fit to answer a written questionnaire.
- For the patient in the chemotherapy group - Chemotherapy after surgery that can be performed before or after radiotherapy
You may not qualify if:
- For all patients:
- Sarcoma or carcinosarcoma;
- Stage FIGO I or IV;
- Macroscopic tumor residue after surgery;
- Recurrence of endometrial cancer or diagnosis of any other cancerous pathology after diagnosis of endometrial cancer (except non-melanotic skin tumors with complete excision), within 5 years;
- drug use;
- Abuse of alcohol.
- For the patient in the chemotherapy group
- Chemotherapy before surgery;
- Chemotherapy concomitant with radiotherapy
- For the patient in the group without chemotherapy
- \- Chemotherapy whether before or after surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Centre François Baclesse
Caen, 14076, France
Centre Oscar Lambret
Lille, France
Centre Eugène Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jean-Michel Grellard
- Organization
- Centre François Baclesse
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- open label
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2018
First Posted
March 15, 2018
Study Start
March 29, 2018
Primary Completion
March 28, 2019
Study Completion
March 28, 2020
Last Updated
December 18, 2025
Results First Posted
December 18, 2025
Record last verified: 2025-12