A Phase II Trial of Erlotinib and Concurrent Palliative Thoracic Radiation Therapy for Patients With Non-small Cell Carcinoma of the Lung. (PEARL Trial)

Ontario Clinical Oncology Group (OCOG)4 个研究点分布在 1 个国家目标入组 40 人开始时间: 2006年11月1日最近更新: 2013年1月29日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 40
试验地点: 4
主要终点: The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To improve the clinical outcomes of patients with non-small cell lung cancer treated with radiation therapy.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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 confirmed non-small cell lung cancer (squamous cell, adenocarcinoma, poorly differentiated non-small cell carcinoma, or some combination of these); and
•Symptomatic patients (defined at discretion of investigator) for whom palliative thoracic radiation is planned (3000cGy/10 fractions); and
•At least 18 years of age.

排除标准

•Previous erlotinib therapy; or
•Planned concurrent chemotherapy; or
•Expected survival of less than 3 months; or
•ECOG Performance Status of 3 or 4; or
•Multiple CNS metastasis or a single CNS lesion that has not demonstrated radiologic stability (screening CT/MRI or head not required); or
•Granulocyte count <1,500/mm3, platelet count <100,000/mm3, or haemoglobin <9.0g/dl; or
•SGOT (AST) or SGPT (ALT) > 2.5 times (x) upper limit of normal (ULN) in the absence of known liver metastases or > 5 x ULN in case of known liver metastases; or
•Alkaline phosphatase (ALP) > 2.5 x ULN; or
•Serum bilirubin > 1.5 ULN; or
•Serum creatinine > 1.5 ULN or creatinine clearance < 60 ml/min; or
•Serum calcium beyond ULN; or
•Patients requiring systemic anti-fungal therapy, clarithromycin, phenytoin, or oral anticoagulation therapy (see Appendix VI for complete list of medications); or
•A history of interstitial lung disease; or
•Known sensitivity to erlotinib; or
•Pregnancy, lactation, or parturition within the previous 30 days; or
•Unwillingness or inability to complete the required assessments of the trial; or
•Mental incompetence, including psychiatric or addictive disorders which would preclude meaningful informed consent; or
•History of recurrent conjunctivitis or keratitis or other inflammatory changes of the surface of the eye.
•Geographically inaccessible for treatment or follow-up evaluations; or
•Involved in an ongoing therapeutic trial.

结局指标

主要结局

The mean improvement of "lung cancer symptoms" as measured by the Lung Cancer Symptom Scale at four weeks following completion of radiation therapy

时间窗: 4 weeks post radiotherapy

次要结局

The improvement in global quality of life and total scores of the LCSS at four weeks following treatment, radiological response, and the incidence and severity of adverse events as per the CTCAE version 3(4 weeks post radiotherapy)

研究者

发起方

Ontario Clinical Oncology Group (OCOG)

申办方类型

Other

责任方

Sponsor

研究点 (4)

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