Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Phase: NA
Conditions: Endometrial Cancer, Chemotherapy Effect, Quality of Life
Sponsor: Centre Francois Baclesse

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SYNOPSIS EndoQol 
 
 
N° ID-RCB: 2017-A02809-44 
 
Version n°2.1  du 22/06/2018 
1 
STUDY SUMMARY 
TITLE 
Impact of adjuvant chemotherapy on the quality of life of patients treated for stage 
II/III endometrial cancer 
ACRONYM 
EndoQoL 
Coordonnator 
Dr Emeline MERIAUX 
Indication 
Endometrial cancer / Quality of life study 
Methodology 
Multicenter case-control study comparing the impact on quality of life of treatment with or 
without adjuvant chemotherapy for FIGO stage II/III endometrial cancer 
Rationale 
 
Endometrial cancer is the fourth most common cancer among women in developed 
countries. It is often diagnosed at a localized stage (67% of cases), which means it has a 
relatively good prognosis, with an 81.7% five-year survival rate across all stages.  
Treatment at the localized stage is based on surgery and radiotherapy. Adjuvant 
chemotherapy may be offered in addition to radiotherapy, but its role is still under debate. It 
is typically delivered sequentially before or after radiotherapy, as concomitant 
chemoradiotherapy is not standard practice. It is generally recommended in stage III cases, 
and for earlier stages, its use depends on various prognostic factors (histological type, 
grade, emboli) and the feasibility of treatment (age, general health, comorbidities). This is 
because patients treated for endometrial cancer are elderly (median age 63) and in most 
cases have comorbidities (diabetes, obesity, and hypertension). 
 
Chemotherapy can cause side effects that can persist and potentially alter the quality of life 
of these often fragile patients. While the impact of surgery and radiotherapy on quality of 
life has been well studied, there is insufficient data in the literature concerning adjuvant 
chemotherapy. It is based on retrospective studies with small sample sizes or longitudinal 
studies that did not assess the specific impact of sequential adjuvant chemotherapy on 
patients' quality of life after treatment. In addition, the chemotherapy protocols used include 
platinum salts and taxanes, which can cause neurological sequelae in these often elderly 
and at-risk patients. 
We propose to conduct a case-control study that will assess 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 treatment, 
comparing their results to a group of patients who were treated with postoperative 
radiotherapy alone.  
Objectives 
Main objective 
To evaluate the impact of adjuvant chemotherapy on overall quality of life in patients with 

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locally advanced endometrial cancer at a distance from their treatment 
Secondary objectives 
- 
Assess long-term symptoms reported by patients that may be related to adjuvant 
chemotherapy, particularly chemotherapy-induced neurotoxicity 
- 
Assess the various areas of quality of life affected in the long term by 
chemotherapy 
- 
To evaluate the impact of adjuvant chemotherapy on physical activity, anxiety, and 
depression 
- 
To evaluate the correlation between immediate toxicity of adjuvant chemotherapy 
and quality of life at a distance from treatment 
- 
To evaluate the correlation between comorbidities and quality of life at a distance 
from treatment 
Inclusion criteria 
 
For all patients (cases and controls) 
- 
Women over the age of 18 with histologically confirmed type 1 or type 2 
endometrial adenocarcinoma, with postoperative FIGO stage II or III, who 
underwent surgery between 2011 and 2015, with at least 2 years since their last 
chemotherapy treatment; 
- 
Recommended surgery: hysterectomy and bilateral salpingo-oophorectomy, 
surgical lymph node staging not mandatory; 
- 
Pelvic radiotherapy ± lumbosacral irradiation, optional brachytherapy; 
- 
No recurrence of endometrial cancer at inclusion; 
- 
No 
history 
of 
progressive 
neurological 
disease 
(multiple 
sclerosis, 
neurodegenerative disease, etc.); 
- 
No history of progressive psychiatric disorders (i.e., hospitalization for psychiatric 
reasons, bipolar disorder, schizophrenia, personality disorders, etc.); 
- 
No objection to data collection; 
- 
Patient deemed capable of completing a written questionnaire. 
 
For case patients 
-    Chemotherapy after surgery, which may be performed before or after 
radiotherapy 
Exclusion criteria 
 
For all patients (cases and controls) 
- 
Sarcoma or carcinosarcoma; 
- 
FIGO stage 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 for completely excised non-
melanocytic skin tumors) within 5 years; 
- 
Drug use; 
- 
Alcohol abuse. 
 
For case patients 
- 
Chemotherapy before surgery; 
- 
Chemotherapy concomitant with radiotherapy 
 
For control patients 
- Chemotherapy either before or after surgery 
Description of 
the 
protocol/experim
ental design 
This is a case-control study conducted as follows: 
1. Identification of patients (cases and controls) meeting the inclusion criteria. 
2. Contacting patients via their referring oncologist to provide information about the 
study and their right to refuse to participate. Patients will be informed either during 
a follow-up consultation or during a telephone interview. 
3. Transmission of the study information form and the right to refuse, and self-
administered questionnaires with a pre-stamped envelope to return them once 
completed, either during a consultation with the referring physician or by post. 

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4. Follow-up phone call one month after sending these documents, if no objection or 
completed questionnaires have been received, with the option of resending the 
documents. 
5. For patients (cases and controls) who have not raised any objections and have 
returned the completed questionnaires, retrospective collection of clinical data at 
each stage of the treatment sequence (preoperative, postoperative, pre-
radiotherapy, 
post-radiotherapy 
± 
chemotherapy) 
and 
during 
follow-up 
consultations (3 months, 6 months, 12 months, and 24 months, and annually 
depending on the time since the end of treatment) from the patients' medical 
records. The following will be collected: medical history (surgical and histological 
data, treatments administered, laboratory tests), medical history, tolerance data, 
adverse events occurring during or following treatment. 
Each patient will be identified by a 3-digit inclusion number, her initials, and her month and 
year of birth. 
The duration of each patient's participation, corresponding to the time needed to complete 
all the questionnaires, is estimated at approximately 1 hour. 
Judgment criteria 
Primary endpoint: 
Overall quality of life score from the QLQ-C30 self-administered questionnaire completed 
remotely after treatment (at least one year after the end of treatment) in patients with locally 
advanced endometrial cancer 
Secondary criteria: 
At least 2 years after the end of treatment:  
•    Functional quality of life scores (physical, functional, social, emotional, and cognitive 
domains) according to the QLQ-C30  
•    Late symptoms potentially related to adjuvant chemotherapy reported by patients: 
• 
Based on symptoms assessed in the QLQ-C30 core questionnaire and its EN24 
module specific to endometrial cancer 
• 
Chemotherapy-induced 
neurotoxicity 
assessed 
using 
a 
specific 
CIPN20 
questionnaire. 
•    Physical activity score according to the IPAQ questionnaire, anxiety/depression score 
according to the HADS scale 
•    Type and grade of toxicities occurring during and in the month following the end of 
chemotherapy according to CTCAE V4.0 criteria 
•    Initial comorbidities (obesity, hypertension, diabetes, cardiovascular disease). 
Sample size 
Our main hypothesis is that patients treated with sequential adjuvant chemotherapy have a 
quality of life more than two years after the end of chemotherapy that remains lower than 
that of patients not treated with chemotherapy. 
In this population of patients with stage II/III endometrial cancer, chemotherapy treatment in 
addition to surgery and radiotherapy should concern less than half of the eligible active 
caseload. We have therefore decided to conduct this study with a ratio of 1 case to 2 
controls. 
A minimum sample size of 39 patients (13 cases and 26 controls) would allow us to detect 
a 10-point difference in the overall quality of life domain (QLQ-C30) between patients who 
received chemotherapy and those who did not (ratio of 1 to 2) with a significance level of 
5% and a power of 80% (t-test with standard deviation equal to 10). In order to anticipate 
any non-evaluable responses, we are increasing this sample size by 15% and plan to 
include at least 45 patients (15 cases who received chemotherapy and 30 controls who 
were treated with surgery and radiotherapy alone). 

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Expected 
benefits 
 
This study will provide information on the experience and tolerance of sequential adjuvant 
chemotherapy in the long term in patients treated for locally advanced endometrial cancer.  
In the context of this disease, which has a relatively favorable prognosis, it will assess 
whether patients with prolonged survival continue to experience side effects long after their 
treatment and whether these effects can be specifically linked to adjuvant chemotherapy, 
particularly neurotoxicity. It will be possible to detail which aspects of their daily lives are 
impacted: anxiety, depression, physical activity, pain, social, emotional, and cognitive 
aspects. Finally, it will be possible to assess whether there is a correlation between the 
experience and immediate toxicity of adjuvant chemotherapy and quality of life long after 
the end of treatment. 
Originality and 
innovative 
character 
Current data in the literature do not allow for a specific assessment of the impact of 
sequential adjuvant chemotherapy on the quality of life of patients with locally advanced 
endometrial cancer, particularly in the long term. This will be the first study to provide this 
information for sequential chemotherapy. 
Elements 
justifying the 
feasibility of the 
project 
Recruitment capacity: with at least 80 eligible patients already identified at the Caen and 
Rouen Cancer Centers, it seems feasible to reach a total of 15 patients treated with 
chemotherapy and 30 patients treated with surgery and radiotherapy alone over a 12-
month period. 
Estimated recruitment period: 1 year. 
Duration of participation for each patient: time required to complete the study 
questionnaires, estimated at 1 hour.  
Scientific competition: no competing studies currently underway. 
Support from a cooperative group: no. 
Planned support from an industry partner: no. 
Participating 
centers  
Names of centers with contact or investigator names: 
- Rouen: Dr. Leheurteur, Henri Becquerel Center 
- Caen: Prof. Joly, François Baclesse Center 
- Rennes: Dr. De La Motte Rouge, Eugène Marquis Center 
- Lille: Dr. Lesoin, Oscar Lambret Center 
- Villejuif: Dr. Pautier, Gustave Roussy Institute