Health Condition 1: C408- Malignant neoplasm of overlappingsites of bone and articular cartilage of limb
Conditions
Interventions
Intervention1: Pioglitazone will be combined with IAP chemotherapy: Tablet Pioglitazone (p.o) will be administered from day minus 5 of cycle 1 neoadjuvant chemotherapy to day plus 21 of cycle 3 neoadj
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: 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 limit of normal AST(SGOT)/ALT(SGPT) 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of good responders (tumour necrosis greater than or equal to 90%Timepoint: Week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Event-free survival 2.Overall survival 3.Grade 3/4 toxicities 4.Degree of weight gain 5.Quality of life assessment Timepoint: -Survival Endpoints- 2-year follow-up period -Toxicities will be captured until the conclusion of all treatment (neoadjuvant chemotherapy, surgery and adjuvant chemotherapy) in both arms. -Weight of the patient will be checked at baseline and prior to every chemotherapy administration. Weight will be rechecked at the 3-month follow-up visit upon conclusion of all treatment. -Quality of life assessment will be concluded at the end of all treatment | — |
Countries
India
Contacts
Public ContactDr Nikita Mehra
Cancer Institute WIA
Outcome results
None listed