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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03466788
Other study ID # EndoQOL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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