Osteosarcoma
Conditions
Interventions
Trade Name: PegIntron
Product Name: PegIntron
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Solution for
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be registered, then following assessment of histological response of primary tumor, may be eligible for randomisation. Registration: 1. Histological evidence of high grade osteosarcoma of the extremity or axial skeleton including those arising as second malignancies 2. Resectable disease 3. Age =40 years at date of diagnostic biopsy 4. Registration within 30 days of diagnostic biopsy 5. Start chemotherapy within 30 days of diagnostic biopsy 6. Neutrophils = 1.5 x 109/L (or WBC = 3 x 109/L if neutrophils are not available) and platelet count = 100 x 109/L 7. Glomerular Filtration Rate =70 mL/min/1.73 m2 8. Serum bilirubin = 1.5 x ULN 9. Sufficient cardiac function to receive anthracyclines: SF = 28% or EF = 50% 10. Adequate performance status (Karnofsky score = 60 or WHO = 2 for patients (age = 16), Lansky score = 60 (age =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria are as follows: 1. Unresectable disease, primary or metastatic or both 2. Low grade osteosarcoma 3. Juxtacortical (periosteal, parosteal) osteosarcoma 4. Craniofacial osteosarcoma 5. Any previous treatment for osteosarcoma 6. Any previous chemotherapy for any disease 7. Any other medical condition precluding treatment with protocol chemotherapy (for example HIV, psychiatric disorder etc) 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective : The principle aim of this study is to find out whether giving extra treatment for osteosarcoma in addition to the standard 3-drug chemotherapy, methotrexate, doxorubicin and cisplatin (MAP), will improve the overall results for patients. Initially, all patients will receive two cycles of pre-operative MAP. After the tumour has been removed by surgery, it will be assessed for histological response: good response is defined as less than 10% viable tumour, poor response is defined as 10% or more viable tumour. The primary objectives of the trial are: 1. To investigate whether the addition of extra chemotherapy agents (ifosfamide and etoposide) to their post-operative chemotherapy improves event-free survival in patients who have a poor response to pre-operative chemotherapy 2. To investigate whether maintenance therapy (interferon alfa) following chemotherapy improves event-free survival in patients who have a good response to pre-operative chemotherapy. ;Secondary Objective: Secondary objectives : To investigate whether the addition of two drugs (ifosfamide and etoposide) to therapy given after surgery for poor responders, and the addition of maintenance therapy (interferon alfa) for good responders, leads to an improvement in overall survival, long and short term toxicities, time to disease recurrence and quality of life. In addition by measuring changes in DNA and other molecules in blood and tumour material, it will seek a method of predicting which patients will benefit most from these treatments ;Primary end point(s): Event-free survival. Events are defined as death, detection of local recurrence or metastases, progression of metastatic disease, or detection of a secondary malignancy. | — |
Countries
Austria, Belgium, Czech Republic, Finland, Ireland, Norway, United Kingdom
Outcome results
None listed