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

Primary Purpose

Endometrial Cancer, Chemotherapy Effect, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self questionnaires of quality of life and living conditions
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre François Baclesse
  • Centre Oscar Lambret
  • Centre Eugène Marquis
  • Centre Henri Becquerel
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients treated with chemotherapy

Patients not treated with chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
February 27, 2018
Last Updated
February 6, 2020
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT03466788
Brief Title
Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Acronym
EndoQOL
Official Title
Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
March 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Chemotherapy Effect, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
open label
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with chemotherapy
Arm Type
Other
Arm Title
Patients not treated with chemotherapy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Self questionnaires of quality of life and living conditions
Intervention Description
Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)
Primary Outcome Measure Information:
Title
The impact in terms of overall quality of life of adjuvant chemotherapy by the QLQ-C30 questionnaire
Description
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
Time Frame
2 years after chemotherapy
Secondary Outcome Measure Information:
Title
Neurotoxicity induced by adjuvant chemotherapy by the CIPN20 questionnaire
Description
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.
Time Frame
2 years after chemotherapy
Title
Different domains of quality of life impacted remotely by chemotherapy by the QLQ-C30 questionnaire
Description
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
Time Frame
2 years after chemotherapy
Other Pre-specified Outcome Measures:
Title
Anxiety by the HADS questionnaire
Description
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).
Time Frame
2 years after chemotherapy
Title
Depression by the HADS questionnaire
Description
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).
Time Frame
2 years after chemotherapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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