NCT03285035Unknown不适用
Quality of Life Assessment in Patients Receiving Cryotherapy in Addition to Chemotherapy for Palliation of Unresectable Esophageal or Gastroesophageal Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
研究概览
简要总结
Cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.
详细描述
This is a single arm prospective study to determine the effect of cryoablation combined with chemotherapy on the quality of life of patients with non resectable esophageal or gastroesophageal cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has esophageal or gastroesophageal cancer and will be receiving chemotherapy
- •Dysphagia score of 1, 2, 3 or
- •Age ≥18 years old
- •American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
- •Deemed not a candidate for esophageal cancer surgical resection
- •Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- •Patient who received radiation treatment in the prior 8 weeks
- •Known brain metastases causing cranial nerve deficits which can cause dysphagia
- •Inability to undergo an esophagogastroduodenoscopy (EGD)
- •Pregnant or nursing
- •Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
- •Patients with tracheoesophageal fistula
结局指标
主要结局
Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 6 months compared to baseline
时间窗: 6 months
次要结局
- Number of participants requiring alternative treatments for dysphagia palliation such as stenting, photodynamic therapy or brachytherapy and stenting(1 year)
- Subjective Global Assessment scale of nutritonal status will be determined at baseline and approximately 3 month intervals.(1 year)
- Immunoassays will be obtained before and after treatment(1 year)
- Tumor length in centimeters, endoscopist estimated luminal diameter and endoscopist subjective assessment of size as compared to the prior endoscopy will be determined(1 to 12 weeks)
- Number of participants with adverse events as assessed by CTCAE 4.03.(30 days)
- Survival while on cryotherapy and systemic chemotherapy will be measured.(1 year)
- Change in baseline quality of life (QOL) assessment using a modified EORTC QLQ-OES18 at 1 to 2 weeks compared to baseline(1 year)
- Change in dysphagia score using the 5 point Likert scale at 1 to 2 weeks post-procedure compared to baseline(1 to 2 weeks)
- local tumor control will be compared to systemic tumor control(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Cryolesion in Treatment of Phantom Limb PainPhantom Limb PainStump NeuralgiaPain, PhantomNCT03415360Military Institute od Medicine National Research Institute50
终止
不适用
Quality of Life After Esophagectomy for Cancer - Step 2Quality of LifeEsophageal CancerNCT01738633University of Padova80
终止
不适用
Quality of Life After Esophagectomy for Cancer - Step 1Sleep DisturbanceQuality of LifeEsophageal CancerNCT01738620University of Padova74
已完成
不适用
Quality of Life During COVID-19 LockdowCTRI/2020/06/025797Dr Anuja Pandit51
已完成
不适用
Evaluation of Quality of Life and Its Influencing Factors After VA-ECMO in Refractory Cardiac Arrest Based on SF-36 Score : A Grenoble Cohort Study From 2006 Through 2018Refractory Cardiac ArrestExtraCorporeal Membrane Oxygenation (ECMO)NCT04601896University Hospital, Grenoble75