Prophylactic Inhaled Steroids to Reduce Radiation Pneumonitis Frequency and Severity in Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0).
研究概览
简要总结
This randomized clinical study aims to assess whether prophylactic treatment with inhaled steroids in patients with locally advanced or concomitantly treated non-small cell lung carcinoma who are candidates for combination treatment with QT/RT or IMT + QT/RT.
The main questions it aims to answer are:
Whether prophylactic treatment decreases the severity of NPR on CTCAE v4.0 and RTOG scales.
Whether inhaled steroid use modifies the response to radiation therapy treatment compared to patients who do not receive prophylactic inhaled steroids.
详细描述
Clinical evaluation
The following BASELINE data shall be taken prior to radiation therapy:
Demographic, clinical, laboratory, and imaging data will be obtained from medical history and electronic records.
The patient will be instructed to perform the PFRs and tests of lung function.
Two EORTC, QLQ-C30, and QLQ LC13 quality of life questionnaires and three respiratory symptom questionnaires (St. George, dyspnea scale, and modified BORG) will be performed on the same day of lung function tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 non-small cell lung cancer (NSCLC) with unresectable locally advanced or metastatic disease (IIIA, IIIB or IV) of the classification tumor node, metastasis (TNM) of malignant lung tumors, 7th edition.
- •NSCLC patients candidates for concomitant treatment (chemotherapy plus radiotherapy or target therapy plus radiotherapy).
- •Evidence of measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, Karnofsky 70-
- •Life expectancy of > 4 months at the time of screening
- •Patients with the ability to comply with the study and follow-up procedures.
- •Patients with previous surgery less than four weeks.
- •Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures.
排除标准
- •Unstable systemic disease: active infection, heart, liver, kidney or metabolic disease; including uncontrolled chronic lung disease.
- •Patients treated with systemic or inhaled corticosteroids.
- •Patients of reproductive age without a family planning method, pregnant or lactating.
- •Previous diagnosis of Pneumonitis with toxicity grade ≥ 2 by CTCAE v4.0 or RTOG scale.
- •Patients with disease progression.
- •Inspiratory flow < 90 liters / min.
- •Discontinue of Treatment
研究组 & 干预措施
Target drug/RT + Budesonide
Patients are receiving target therapy and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.
干预措施: Inhaled budesonide (Drug)
QT/RT + Budesonide
Patients are receiving chemotherapy (QT) and radiotherapy (RT) plus inhaled Budesonide with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.
干预措施: Inhaled budesonide (Drug)
结局指标
主要结局
Pneumonitis graded by the Common terminology criteria for adverse event v4.0. (CTCAE v4.0).
时间窗: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic or mild respiratory symptoms, Grade 2: Moderate respiratory symptoms of pneumonitis (a severe cough) and radiographic changes (radiographic patches), Grade 3: Severe respiratory symptoms of pneumonitis, dense radiographic changes. Grade 4: Symptoms of acute respiratory failure requiring assisted ventilation or continuous oxygen. Grade 5: Death directly related to late effects of radiotherapy.
Pneumonitis graded by the Radiation Therapy Oncology Group score (RTOG)
时间窗: from the beginning of radiotherapy up to 1 year after the 1st session.
Current score for radiation pneumonitis according to symptoms and radiographic changes. Grade 0: No changes, Grade 1: Asymptomatic, only radiological or tomographic findings, Grade 2: Symptomatic, does not interfere with daily activities, Grade 3: Symptomatic, interferes with daily activities, requires supplemental oxygen. Grade 4: Threatens life, needing ventilator support. Grade 5: Severe pneumonitis with fatal outcome.
次要结局
- Cognitive functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Emotional Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment)
- Role Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Lung cancer-associated symptoms assessment(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Treatment-related side effects in lung cancer(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Physical functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Pulmonary function evaluation using spirometry test(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment)
- Social Functioning evaluated by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Respiratory symptoms evaluation using St. George respiratory questionnaire(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Dyspnea assessment by the Borg Scale Dyspnea Index (BSDI)(before the start Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Pulmonary function evaluation using diffusion lung capacity of carbon monoxide measurement (DLCO).(before the start of Radiotherapy and at 6, 12, 24 and 48-weeks post-treatment.)
- Pulmonary function evaluation using Impulse oscillometry test (IOS)(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
- Airway inflammatory response evaluation using the fraction of exhaled nitric oxide measurement (FeNO)(before the start of Radiotherapy, and at 6, 12, 24 and 48-weeks post-treatment.)
研究者
Oscar Gerardo Arrieta Rodríguez
Head of the Thoracic Oncology unit
Instituto Nacional de Cancerologia de Mexico