Impact of Early Palliative Care on Overall Survival of Patients With Metastatic Upper Gastrointestinal Cancers, Treated With First-line Chemotherapy: a Randomized Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 31
- 主要终点
- Overall survival (as intent-to treat analysis)
研究概览
简要总结
This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).
详细描述
Medical oncology is aimed to increase patient's survival, even at metastatic stages, in addition to disease-related and treatment-related symptoms. However, providing palliative care (PC) which includes symptoms management, nutritional support, psychosocial support, as well as assistance on end-of-life preferences, may be as important as survival issues to improve quality of life in such setting. In France, PC has been traditionally offered late, at end-life stage, although the World Health Organization recommends providing PC as earlier as possible in the course of the disease, in order to increase quality of life.
Decades ago, PC services were initiated in France in order to provide a medical alternative to the use of questionable medical practices regarding the end of life period: abandonment, euthanasia, and inappropriate aggressive therapy. According to the French society of palliative care, PC is an approach aimed to provide active care, in a holistic approach, to the person with a serious, progressive or terminal illness. The objective of PC is to relieve pain and other distressing symptoms, but also to take into account the psychological, social and spiritual suffering. PC offers an interdisciplinary support system to help patients and their relatives. As mentioned previously, PC has been in France (but also in the US) usually offered late, at end-life stage. Actually, PC access became a Right guaranteed by the Law, for patients and their families in 1999. This context should explain why even nowadays, PC often means " end of life " not only for the lay-man for the general public but also for caregivers, and some doctors.
The last World Health Organization (WHO) recommendations are far less restrictive than the 1996 French recommendations, as it is stated that PC should be offered as earlier as possible in the course of the disease, in order to increase quality of life, and to positively influence the course of illness. The World Health Organization recommendations add that PC is applicable early in the course of illness, in conjunction with other therapies that are intended to prolong life, such as chemotherapy or radiation therapy, and includes those investigations needed to better understand and manage distressing clinical complications.
In a recent randomized study, 151 patients with newly diagnosed metastatic non-small-cell lung cancer were randomized to receive either early PC (EPC) combined with standard oncologic care or standard oncologic care alone. It was hypothesized that patients, who received EPC, compared with patients who received standard oncologic care only, would have a better quality of life (primary endpoint). The first visit with the PC service set up within the first 12 weeks, and the median number of visits in the EPC group was 4. In this study, the authors referred to the recommendations of the National Consensus Project for Quality Palliative Care. Among patients with metastatic non-small-cell lung cancer, EPC led to significant improvements in quality of life. In addition, EPC led to significant improvements in mood, as well as in overall survival (median survival, 11.6 vs. 8.9 months; HR=0.60, p = 0.02)), despite less aggressive end-of-life care.
Following the publication of this American study, the American Society of Clinical Oncology recommends nowadays that "combined standard oncology care and PC should be considered earlier in the course of the illness for any patient with metastatic cancer....". However, it is clear that a gap exists (not only in France) between this recommendation and the current practice. In addition, there is no consensus on how early PC should be integrated in oncologic services, even though an underpowered small randomized trial reported recently an insignificant better survival favoring early versus delayed (3 months later) initiation of PC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an upper gastrointestinal metastatic cancer: pancreatic, biliary tract, esophageal or gastric (including junctional Siewert 2 and 3 cancers) cancers.
- •NB: gastrooesophageal junctional cancers with dysphagia and/or gastric/gastrooesophageal cancers with unknown or positive HER2 status are not eligible.
- •Patients planed to be treated with first-line chemotherapy for metastatic disease.
- •Age ≥ 18 years
- •Life expectancy ≥ 1 month
- •Performance status (OMS) ≤ 2
- •Good understanding of French language
- •Signed and dated informed consent
- •Patients covered by government health insurance
排除标准
- •Locally advanced cancer
- •Junctional Siewert 1 gastrooesophageal cancer
- •Gastric or junctional gastrooesophageal cancer with dysphagia (Atkinson>2)
- •Gastric or junctional gastrooesophageal cancer with unknown or positive HER2 status (IHC: +++ or IHC ++ and FISH/SISH +)
- •Compression of the biliary tract requiring a bypass
结局指标
主要结局
Overall survival (as intent-to treat analysis)
时间窗: An average of 1 year
The overall survival is defined as the time between the date of randomization and the date of death, whatever the cause.
次要结局
- Quality of life assessed with the QLQ-C30(every 8 weeks until the patient withdrawal from the study (during an average of 1 year))
- Overall survival (per protocol analysis)(An average of 1 year)
- One year survival rate (intent-to treat and per protocol analyses)(1 year)
- Depression assessed with the HADS score(every 8 weeks during 24 weeks)
- TUDD (Time Until Definitive Deterioration)(An average of 1 year)
- Presence or lack of advanced directives(through study completion, an average of 1 year)
- Number of patients treated with chemotherapy(30 days before death of the patient)
- Questionnaire "content of PC visits"(during the 6 first months after randomization)
