Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer (EndoQOL)

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Endometrial Cancer; Chemotherapy Effect
• Intervention / Treatment: Other: Self questionnaires of quality of life and living conditions

Detailed Description

Endometrial cancer is the fourth most common cancer in women in developed countries. The diagnosis is often made at a localized stage (67% of cases), making it a relatively good cancer prognosis with a 5-year all-stage survival of 81.7%.

Its management at the localized stage is based on surgery and radiotherapy. Adjuvant chemotherapy may be offered in addition to radiotherapy, but its place is still debated. It is classically delivered sequentially before or after radiotherapy, concomitant radiochemotherapy not being a standard. It is generally recommended in case of stage III, and for the earlier stages, its use is based on various prognostic factors (histological type, grade, emboli) and the feasibility of treatment (age, general condition, comorbidities). In fact, patients treated for endometrial cancer are elderly (median age 63 years) and in the majority of cases present comorbidities (diabetes, obesity and hypertension). Chemotherapy can induce side effects that can persist and potentially alter the quality of life of these often fragile patients. Although the impact of surgery and radiotherapy on the quality of life has been well studied, there is insufficient literature data for adjuvant chemotherapy. The investigator propose a case-control study that will evaluate the quality of life and late sequelae of patients treated for locally advanced endometrial cancer with sequential adjuvant chemotherapy before or after radiotherapy at a distance from their management. comparing their results to a group of patients who had been treated with postoperative radiotherapy alone.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14076
    • Centre Francois Baclesse
  • Lille, France
    • Centre Oscar Lambret
  • Rennes, France
    • Centre Eugene Marquis
  • Rouen, France
    • Centre Henri Becquerel
  • Villejuif, France, 94805
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients treated with chemotherapy	Other: Self questionnaires of quality of life and living conditions; Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)
Other: Patients not treated with chemotherapy	Other: Self questionnaires of quality of life and living conditions; Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire	The quality of life Questionnaire Chemotherapy Induced Peripheral Neuropathy (QLQ-CIPN20) is a questionnaire specifically dedicated to the evaluation of peripheral neuropathies induced by chemotherapy. This quality of life questionnaire is composed of 20 items from 0 to 4 and has been tested in a large international clinical trial. Here is the sensory scale, ranging from 0 to 100, with high scoring indicating high symptom of neuropathy	2 years after chemotherapy
Different Domains of Quality of Life Impacted Remotely by 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. QLQ-C30 scoring cinludes 5 functionning scales (physical, role, emotional, cognitive and social), ranging from 0 to 100, with high score indicating high level of quality-of-life. QLQ-C30 scoring includes 9 symptom scales (fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties), ranging from 0 to 100, with high score indicating poor level of quality-of-life.	2 years after chemotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety by the HADS Questionnaire	The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the scale of Anxiety, ranging from 0 to 21, with high score reflecting high level of anxiety.	2 years after chemotherapy
Depression by the HADS Questionnaire	The Hospital Anxiety and Depression Scale (HADS) It is a quick and easy self-questionnaire that assesses both anxious and depressive dimensions (7 items for each dimension). Here is the depression scale, ranging from 0 to 21, with high score indicating high level of depression.	2 years after chemotherapy

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): March 28, 2020

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 15, 2018

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms; Socioeconomic Factors; Population Characteristics; Social Conditions
• Other Study ID Numbers: EndoQOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No