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

Not Applicable

Completed

• Conditions: Chemotherapy Effect; Endometrial Cancer; Quality of Life
• Interventions: Other: Self questionnaires of quality of life and living conditions

• Registration Number: NCT03466788
• Lead Sponsor: Centre Francois Baclesse

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

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 Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-15
• Study Start: 2018-03-29
• Primary Completion: 2019-03-28
• Study Completion: 2019-03-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients not treated with chemotherapy	Self questionnaires of quality of life and living conditions	-
Patients treated with chemotherapy	Self questionnaires of quality of life and living conditions	-

Primary Outcome Measures

Name	Time	Method
The impact in terms of overall quality of life of adjuvant chemotherapy by the QLQ-C30 questionnaire	2 years after chemotherapy	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

Secondary Outcome Measures

Name	Time	Method
Neurotoxicity induced by adjuvant chemotherapy by the CIPN20 questionnaire	2 years after chemotherapy	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.
Different domains of quality of life impacted remotely by chemotherapy by the QLQ-C30 questionnaire	2 years after chemotherapy	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

Trial Locations

Locations (5)

Centre Henri Becquerel; 🇫🇷 Rouen, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France