Clinical trial NCT03466788: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Official title: Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Chemotherapy Effect
Quality of Life
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The impact in terms of overall quality of life of adjuvant chemotherapy by the QLQ-C30 questionnaire
timeFrame: 2 years after chemotherapy
Secondary outcomes:
measure: Neurotoxicity induced by adjuvant chemotherapy by the CIPN20 questionnaire
timeFrame: 2 years after chemotherapy
measure: Different domains of quality of life impacted remotely by chemotherapy by the QLQ-C30 questionnaire
timeFrame: 2 years after chemotherapy
Other outcomes:
measure: Anxiety by the HADS questionnaire
timeFrame: 2 years after chemotherapy
measure: Depression by the HADS questionnaire
timeFrame: 2 years after chemotherapy
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: