Trans Tasman Radiation Oncology Group (TROG) 03.07 - A randomised phase II study of two regimens of palliative chemoradiation therapy (Vinorelbine and cisplatin OR Gemcitabine) in the management of locally advanced and metastatic non-small lung cancer to improve response rate.

Bryan Burmeister0 个研究点目标入组 80 人开始时间: 2003年12月22日最近更新: 2020年1月13日

适应症

试验速览

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•Histologically or cytologically proven non-small cell lung cancer.- Planned high dose palliative radiation therapy for locoregional control. Examples include patients with: a) Stage I – IIIB disease with: -disease technically unsuitable for radical therapy, or -weight loss in excess of 10%, or -concurrent medical illness b)Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a Flurodeoxyglucose-Positron Emission Tomography (FDG-PET) only solitary metastasis.- All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.- No prior radiotherapy or chemotherapy for non-small cell lung cancer. - European Cooperative Ooncology Group performance status 0, 1.- Adequate hepatic, bone marrow and renal function.- If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.- Written informed consent.

•Patient unable to receive all therapy as an outpatient.- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.- Receiving treatment with another investigational agent.

发起方

Bryan Burmeister