Evaluating the Efficacy of Pioglitazone in combination with Neoadjuvant Chemotherapy in Patients with Extremity Skeletal High-Grade Osteosarcoma Treated with Curative Intent: A Multi-centre, Randomized Phase II Clinical Trial
- Conditions
- Health Condition 1: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb
- Registration Number
- CTRI/2021/09/037015
- Lead Sponsor
- Cancer Institute WIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method