The feasibility of weekly paclitaxel in improving performance status of advanced NSCLC patients with poor performance status: A single arm phase two trial - ImPACt

All India Institute of Medical Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Cytologically/pathologically confirmed NSCLC either stage 4 disease or those stage IIIC not amenable to definitive chemoradiation. (AJCC 8th)
•2.ECOG Performance status more than or equal to 2 ECOG with:
•i.Charlson comorbidity index of less than 9
•ii.Comorbidities, if any, should be controlled.
•iii.Serum albumin more than or equal to 3.5g/dl
•iv. Acceptable renal and liver function,
•v.eGFR of more than or equal to 30ml/min,
•vi.LFT with Bilirubin less than 2 times ULN and transaminases less than 3 times ULN
•vii.Adequate bone marrow function:Hb of more than or equal to 8g/dl,Platelet count of more than or equal to 1,00,000/mm3,ANC of more than or equal to 1500/mm3
•3.Able to understand the PIS (patient information sheet) and give informed consent

•1.Active malignancy other than NSCLC
•2.Lactating and pregnant woman
•3.HIV positive patients
•4.Driver mutation positive: EGFR/ALK/ROS1
•(Patients who have unknown or awaited status of these driver mutations will be eligible, however, if during the study, they are found to harbour these mutations, they will be out of the study.)
•5.Symptomatic untreated brain metastasis.
•(Asymptomatic incidentally detected brain metastasis and treated brain metastasis will not be excluded.)

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