JPRN-jRCTs031200230招募中3 期
JCOG1914: A phase III study of daily low-dose carboplatin versus weekly carboplatin plus nab-paclitaxel and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer - Elderly-NSCLC CBDCA/RT vs CBDCA/Nab-PTX/RT
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically proven non-small cell lung cancer.
- •(2) Diagnosed as unresectable c-stage III and also fulfills at least one of the following conditions on imaging studies. (Excluding postoperative recurrence)
- •(i) N0-1 and presence of direct invasion into the parietal pleura, chest wall, phrenic nerve, or pericardium.
- •(ii) N0-1 and presence of direct invasion into the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina, or separate tumor in different love of ipsilateral lung.
- •(iii) N2-3 with any T.
- •(iv) Judged unresectable by both an oncologist and a thoracic surgeon.
- •(3) Aged 75 years and older at the time of enrollment.
- •(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •(5) IMRT or 3D-CRT according to the protocol is considered possible by a radiation oncologist.
- •(6)No previous chemotherapy and radiotherapy against the lung cancer
- •(7) If prior history of radiotherapy is present, the patient fulfills both of the following requirements.
- •(i) No past radiotherapy to the hilums of the lungs or the mediastinum.
- •(ii) No prior history of radiation pneumonitis of grade 2 or higher.
- •(8) Sufficient org an function. (Results of tests performed within 14 days prior to enrollment.)
- •(i) Neutrophil count >= 1,500/mm3
- •(ii) Hemoglobin >= 9.0 g/dL (transfusion within 14 days prior to the blood test is not allowed)
- •(iii) Platelet count >= 100,000 /mm3
- •(iv) Total bilirubin <= 1.5 mg/dL
- •(v) Asparate aminotransferase <= 100 U/L
- •(vi) Alanine aminotransferase <= 100 U/L
- •(vii) Creatinine <= 1.2 mg/dL
- •(viii) SpO2 >= 93%
- •(9) Written informed consent.
排除标准
- •(1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.)
- •(2) Active infection requiring systemic therapy.
- •(3) Fever with a body temperature higher than 38.0 degrees Celsius at the time of enrollment.
- •(4) Psychiatric illnesses or symptoms affecting daily lives.
- •(5) Systemic administration of steroids or immunosuppressive agents.
- •(6) Uncontrolled diabetes.
- •(7) Unstable angina (diagnosis or worsening of chest pain within 3 weeks); history of myocardial infarction within 6 months prior to enrollment; or uncontrolled heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
- •(8) Interstitial pneumonia, pulmonary fibrosis on chest CT.
- •(9) Complications such as a total unilateral lung atelectasis or an obstructive pneumonia.
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