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

NCT ID: NCT03466788

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-29
• Study Completion Date: 2020-03-28

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.

Conditions

Endometrial Cancer; Chemotherapy Effect; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Patients treated with chemotherapy

Group Type: OTHER

Self questionnaires of quality of life and living conditions

Intervention Type: OTHER

Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)

Patients not treated with chemotherapy

Group Type: OTHER

Self questionnaires of quality of life and living conditions

Intervention Type: OTHER

Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre François Baclesse

Caen, , France

Centre Oscar Lambret

Lille, , France

Centre Eugène Marquis

Rennes, , France

Centre Henri Becquerel

Rouen, , France

Institut Gustave Roussy

Villejuif, , France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

EndoQOL

Identifier Type: -

Identifier Source: org_study_id