N/A
N=50
Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Endometrial Cancer · Chemotherapy Effect · Quality of Life
Bottom Line
View on ClinicalTrials.gov: NCT03466788 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire — 61.7; 71.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self questionnaires of quality of life and living conditions (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Centre Francois Baclesse
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire |
61.7; 71.1 | — |
| SECONDARY Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire |
20.04; 6.86 | — |
| SECONDARY Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire |
75.3; 76.8; 77.2; 80.7; 67.1; 79.5 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03466788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.