NCT00136864已完成3 期
The Impact of Positron Emission Tomography (PET) Imaging in Stage III Non-small Cell Lung Cancer: A Prospective Randomized Clinical Trial (PET START Trial)
Ontario Clinical Oncology Group (OCOG)10 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2004年8月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 10
- 主要终点
- Stage III NSCLC patients upstaged by PET
研究概览
简要总结
Locally advanced non-small cell lung cancer, NSCLC, (Stage III) is potentially curable with aggressive combined modality therapy (chemotherapy and radiation). Conventional imaging can only evaluate gross anatomic abnormalities but functional imaging with positron emission tomography (PET) may more accurately identify patients who will benefit from aggressive combined modality therapy.
This prospective randomized clinical trial will enroll 400 patients that have undergone conventional staging for lung cancer and have been found to have Stage III NSCLC. The patients will then be randomized to either standard combined modality therapy for Stage III NSCLC or to PET imaging prior to combined modality therapy with curative intent. Based on the PET findings, patients will either be suitable for combined modality therapy with curative intent or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Histological or cytological evidence of NSCLC. Must have documented pathology report with histology indicated (e.g. squamous, adenocarcinoma, large cell, NSCLC not otherwise specified).
- •Stage III (mediastinal node positive) NSCLC based on conventional staging (e.g. computed tomography [CT] scan of chest and upper abdomen, CT or magnetic resonance imaging [MRI] of brain, bone scan).
- •Suitable for combined modality (chemotherapy and radiation) therapy or radical radiation therapy or trimodality therapy (chemotherapy, radiation and surgery).
排除标准
- •Stage IV NSCLC (by conventional staging).
- •Small cell lung cancer.
- •Poor performance status Eastern Cooperative Oncology Group (ECOG) 3-
- •Poor pulmonary function precluding radical radiation therapy (Adequate pulmonary reserve for radical radiation therapy. Pulmonary function tests should have forced expiratory volume in 1 second (FEV1) > 1.0 liter or > 40% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) > 45% and/or predicted contralateral FEV1 > 800 cc based on quantitative ventilation perfusion lung scan).
- •Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease).
- •Insulin dependent diabetic where requirements for PET imaging may be problematic.
- •Unable to lie supine for at least 30 minutes in radiation treatment position for imaging with PET.
- •Failure to provide informed consent.
- •Previous PET scan relating to recent cancer diagnosis prior to entry into study.
- •Pregnant or lactating females.
- •Prior thoracic radiation.
- •Prior malignancy within 3 years from randomization (except nonmelanotic skin cancer or carcinoma in situ of the cervix).
- •Administered more than two cycles of chemotherapy prior to radical radiation therapy or concurrent chemoradiation (as part of induction or sequential chemotherapy prior to randomization) for the current malignancy.
结局指标
主要结局
Stage III NSCLC patients upstaged by PET
时间窗: 2 years
次要结局
- Overall survival(2 years)
- Impact of PET on radiation treatment planning(2 years)
- Prognostic ability of PET standard uptake value(2 years)
- Number of patients downstaged by PET(2 years)
研究者
研究点 (10)
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