Phase II analysis for efficacy and safety of perioperative pirfenidone (Pirespa) therapy for patients with non-small cell lung cancer combined with idiopathic pulmonary fibrosis (IPF) - Perioperative pirfenidone for lung cancer with fibrosis evaluation (PEOPLE)

West Japan Oncology Group0 个研究点目标入组 42 人开始时间: 2012年4月16日最近更新: 2023年10月17日

适应症

试验速览

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•1)History of thoracotomy or video-assisted thoracoscopic surgery (We accept the patients who have the history of surgical biopsy for diagnosing IPF more than 6 months ago.) 2) Treatment history of IPF (e.g., pirfenidone, steroid, erythromycin, and immunosuppressors) before registration. When these drugs which can become the treatment of IPF were used even if for other diseases, we exclude this case. 3) History of radiation therapy (which include a lung in the treatment field) or chemotherapy. 4) Other known causes of interstitial pneumonia (e.g., environmental exposures, connective tissue disease, and drug toxicity). 5) Induced oxygen therapy 6) Local or systemic active infection which requires treatment. 7) Severe complications (e.g., bleeding from digestive organs, heart diseases, glaucoma, and diabetes). 8) History of severe hypersensitivity. 9) Mental diseases which prevent from registration of this trial. 10) Pregnant ladies, nursing ladies, the ladies with possibility of pregnancy, or the ladies who does not have intention to prevent pregnancy. 11) Obvious history of acute exacerbation of IPF. 12) Judged as inappropriate for this trial by the medical attendant by other reasons.

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