Efficacy of Pioglitazone in combination with Neoadjuvant Chemotherapy in Patients with Extremity Skeletal High-Grade Osteosarcoma Treated with Curative Intent: An Open-label, Multi-centre, Randomized Phase II Clinical Trial

Cancer Institute WIA0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients with newly diagnosed extremity high-grade osteosarcoma with 4 or less lung metastases detected radiologically (up to 4 lung lesions unilateral or 2 on each side if bilateral â?? should be resectable)
•ECOG performance status 0-2
•No active infection(s) at the time of randomization
•Patients must have normal cardiac function
•Patients must have normal organ and marrow function as defined below:
•Leukocytes more than 3000/mcl
•absolute neutrophil count more than 1500/mcl
•platelets more than 100000/mcl
•total bilirubin <1.5 X institutional upper
•limit of normal
•AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
•Creatinine within normal institutional limits OR
•Creatinine clearance >60 ml/min/1.73 m2 for patients with levels above institutional normal Participants capable of childbearing should use adequate contraception (except oral contraceptive pills)

•Patients with high-grade extremity osteosarcoma with non-pulmonary metastatic disease or more lung lesions than permitted in the inclusion criteria
•Patients with severe/ uncontrolled comorbidity precluding use of multi-agent chemotherapy
•Hepatitis B positive
•Hepatitis C positive
•HIV positive
•Active tuberculosis on anti-tuberculous treatment
•Psychiatric illness/social situation that would limit compliance with study requirements
•History of epilepsy on anti-epileptic drugs
•Positive pregnancy test in women of childbearing potential
•Pregnant and lactating women
•Past history of ischemic heart disease or cardiac failure
•Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
•Known case of diabetes mellitus
•History of previous malignancy

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