Randomized Controlled Clinical Study of Folic Acid Treatment of Radiation Esophagitis After Chemoradiation in Lung Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Progression-free survival(PFS)
研究概览
简要总结
This randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.
详细描述
By prospective randomized controlled study, this study research plans to recruit with diagnosis of lung cancer patients, according to whether there is drug intervention were divided into treatment group and control group, compared two groups of acute radiation esophagitis in the before and after the intervention, extent of occurrence of folic acid and clinical curative effect, so as to verify whether folic acid can be used as an intervention in the treatment of radioactive esophagitis, To explore the safety of folic acid in the treatment of radioactive esophagitis and explore the standardized treatment of radioactive esophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant lung cancer (incluedig Non-small cell lung cancer, small cell lung cancer) diagnosed by histopathology or cytology.
- •TNM Stage N2~N3 (IASLC International TNM staging standard for Lung Cancer, 8th edition) was indicated by radiotherapy and the patients were treated for the first time.
- •Aged between 18 and 75 years old,no limit on the gender.
- •ECOG≤2 or KPS≥
- •No contraindication of Concurrent chemoradiotherapy.
- •Patients without important organ dysfunction,hematology: it is within the normal range according to the standards of each laboratory; Cardiac function: normal range; Liver function: normal range; Renal function: normal range; Pulmonary function: FEV1 > 50%, mild to moderate impairment of pulmonary function.
- •Patients with good compliance to treatment received and follow-up.
排除标准
- •Prior to treatment, there were other esophageal diseases, such as gastrointestinal ulcer, reflux esophagitis, cardia relaxation.
- •Patients with severe nutritional anemia prior to treatment.
- •The IV stage patients with uncontrolled malignant pleural effusion,with diffuse liver or lung metastasis which lead to liver or pulmonary dysfunction.
- •Patients with severe heart, lung or kidney diseass,such as uncontrolled hypertension, diabetes, unstable angina, a history of myocardial infarction or heart failure, or uncontrolled arrhythmias; There is clearly clinically diagnosed heart valve disease; The active phase of a bacterial, fungal, or viral infection; Mental disorders; Severely impaired lung function.
- •A history of previous tumors complicated with other malignant tumors.
- •The pregnant or breast-feeding patients.
- •Patients with mental and neurological diseases.
研究组 & 干预措施
Experimental
Folic acid intervention
干预措施: Folic acid (Drug)
结局指标
主要结局
Progression-free survival(PFS)
时间窗: up to 12 months
PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(day 1 up to 4 weeks after the end of treatment)
- Severity of radiation esophagitis(day 1 up to 4 weeks after the end of treatment)