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

Quality of Life Clinical Trial

— EndoQOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03466788
• Other study ID #: EndoQOL
• Status: Completed
• Phase: N/A
• Start date: March 29, 2018
• Est. completion date: March 28, 2019

Study information

• Verified date: February 2020
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 28, 2019
• Est. primary completion date: March 28, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy Effect
• Endometrial Cancer
• Endometrial Neoplasms
• Quality of Life

Intervention

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)

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Oscar Lambret	Lille
France	Centre Eugène Marquis	Rennes
France	Centre Henri Becquerel	Rouen
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	2 years after chemotherapy
Other	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).	2 years after chemotherapy
Primary	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	2 years after chemotherapy
Secondary	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.	2 years after chemotherapy
Secondary	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. It is currently used in many clinical trials in oncology	2 years after chemotherapy