Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Weprom
- 入组人数
- 133
- 试验地点
- 9
- 主要终点
- Overall Survival (OS)
- 状态
- 已完成
- 最后更新
- 5年前
概览
简要总结
This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.
详细描述
With a 5-year survival of about 15% pulmonary cancer is very poor prognosis. About 70 to 75% of cancers are diagnosed at advanced stages. Relapses are common and rarely curable. At least 75% of relapses are symptomatic and there is no standard monitoring after curative treatment or not. Currently, the most common monitoring strategy involves the completion of a clinical examination every 3 to 6 months associated with chest X-ray or CT-scan. An intensive clinical and imaging monitoring has not yet shown any survival advantage but monitoring of symptoms appears to have a significant medical and economic advantage compared to imaging monitoring. This non-personalized approach is a source of anxiety for patients, especially with the approach of the date of the imaging assessment. In contrast, this monitoring can leave symptomatic patients with untreated relapse for several weeks because many symptomatic patients wait the date of the imaging assessment to consult. the investigators have developed a score based on the dynamics and the association of clinical signs to alert the physician to a possible recurrence of lung cancer. The referring physician is alerted so early and convenes the patient for a checkup. One of the explanations which could demonstrate the gain in survival is the possibility offered by the application SENTINEL is to treat the relapses earlier, thus avoiding to wait a too much important deterioration of general condition between two monitoring follow-up more or less spaced.
研究者
入排标准
入选标准
- •Patient with lung cancer (NSCLC and SCLC), histologically proven
- •Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
- •Age ≥ 18 ans
- •PS ≤ 2 within 15 days before enrollment
- •Patient having:
- •finished his cancer treatment in the last 3 months by:
- •Surgery or
- •Surgery then adjuvant chemotherapy or
- •Concomitant radio-chemotherapy or
- •Conventional or stereotactic radiotherapy or
排除标准
- •Patient whose disease has progressed at the end of the specific treatment
- •Symptomatic brain metastases
- •Persons deprived of liberty or under guardianship or curators
- •Dementia, mental alteration or psychiatric pathology that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
- •Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
- •Pregnant or breastfeeding women
- •Patient participating in another interventional study
结局指标
主要结局
Overall Survival (OS)
时间窗: 24 months
Overall survival is defined as the period between the date of randomization to the date of death from any cause. We will also evaluate in this context the overall survival defined between the date of diagnosis and date of death whatever the cause in order to know more precisely the duration of the disease.
次要结局
- Quality of Life (QOL)(12 month)
- Relapse detection time(24 month)
- Performance Status (PS)(24 month)
- Cost of monitoring(24 month)
- Patient compliance(24 month)
- Depression(12 month)