NCT02790190Unknown3 期
Phase III Study of Individualized Adaptive Radiotherapy Based on PET/CT and 3DCRT/IMRT in Combination With Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)
Shandong Cancer Hospital and Institute24 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2015年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 400
- 试验地点
- 24
- 主要终点
- Overall survival
研究概览
简要总结
This is a perspective, multicenter,randomized controlled trial to compare the efficacy and safety of radiotherapy Based on PET/CT and IMRT combined with concurrent chemotherapy in patients with locally advanced non small cell lung cancer . Analyses of overall survival (OS) will be done as defined in the protocol.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven non-small cell lung cancer.
- •Patients must be clinical AJCC stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multidisciplinary treatment team.
- •Patients with multiple, ipsilateral pulmonary nodules (T3, or T4) are eligible if a definitive course of daily fractionated RT is planned.
- •Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
- •History/physical examination, including documentation of weight, within 2 weeks prior to registration;
- •CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration;
- •CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration;
- •Pulmonary function tests, including DLCO, within 6 weeks prior to registration; patients must have FEV1 ≥ 1.2 Liter or ≥ 50% predicted without bronchodilator;
- •Zubrod Performance Status 0-1 within 2 weeks prior to registration;
- •Able to tolerate PET/CT imaging required to be performed at an ACR Imaging Core Lab qualified facility;
- •CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function;
- •Serum creatinine within normal institutional limits or a creatinine clearance ≥ 60 ml/min within 2 weeks prior to registration;
- •The patient must provide study-specific informed consent prior to study entry.
排除标准
- •Any component of small cell lung carcinoma.
- •Evidence of a malignant pleural or pericardial effusion .
- •Prior invasive malignancy (except nonmelanomatous skin cancer) in 3 years ;
- •Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
- •Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
- •Pregnancy or women of childbearing potential and men who are sexually active and not willing to use medically acceptable forms of contraception.
- •Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) ;
- •Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded.
结局指标
主要结局
Overall survival
时间窗: 24 months
次要结局
- local control rate(24 months)
- Progression free survival(24 months)
- Objective response rate(24 months)
研究者
Jinming Yu
president
Shandong Cancer Hospital and Institute
研究点 (24)
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