Impact of Adjuvant Chemotherapy on the Quality of Life of Patients Treated for Stage II / III Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The Impact in Terms of Overall Quality of Life of Adjuvant Chemotherapy by the QLQ-C30 Questionnaire
时间窗: 2 years after chemotherapy
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. Here is the glodal health status scale of the QLQ-C30 questionnaire, ranging from 0 to 100, with high score indicating good quality of life.
次要结局
- Neurotoxicity Induced by Adjuvant Chemotherapy by the CIPN20 Questionnaire(2 years after chemotherapy)
- Different Domains of Quality of Life Impacted Remotely by Chemotherapy by the QLQ-C30 Questionnaire(2 years after chemotherapy)