Osteosarcoma Cancer Osteosarcoma
Conditions
Interventions
All patients who are registered on this study will receive pre-operative chemotherapy with MAP for about 10 weeks. Following surgery for the primary tumour, the histological response to pre-operative
Sponsors
Medical Research Council (UK)
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. Patients must fulfill the following criteria for registration into the trial: 1. Histological evidence of high grade osteosarcoma of the extremity or axial skeleton including those arising as second malignancies 2. Resectable disease 3. Aged 40 years or less at date of diagnostic biopsy 4. Registration within 30 days of diagnostic biopsy 5. Start chemotherapy within 30 days of diagnostic biopsy 6. Neutrophils more than or equal to 1.5 x 10^9/L (or white blood cell count [WBC] more than or equal to 3 x 10^9/L if neutrophils are not available) and platelet count more than or equal to 100 x 10^9/L 7. Glomerular Filtration Rate more than or equal to 70 ml/min/1.73 m^2 8. Serum bilirubin more than or equal to 1.5 x Upper Limit of Normal [ULN] 9. Sufficient cardiac function to receive anthracyclines: shortening fraction (SF) more than or equal to 28% or ejection fraction (EF) more than or equal to 50% 10. Adequate performance status (Karnofsky score more than or equal to 60 or World Health Organisation [WHO] less than or equal to two for patients [aged 16 or over], Lansky score more than or equal to 60 [aged under 16]). Patients whose performance status is adversely affected by a pathologic fracture but who are able to undergo treatment are eligible. 11. Patient fit to undergo protocol treatment and follow-up 12. Written informed consent
Exclusion criteria
Exclusion criteria: 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 Human Immunodeficiency Virus [HIV], psychiatric disorder etc.) 8. Pregnant or lactating women Patients must fulfill the following criteria for randomisation into the trial: 1. Assessment of histological response in primary tumor within 35 days of definitive surgery 2. Exactly two courses of cisplatin and doxorubicin must have been administered before surgery 3. At least two courses and no more than six courses of methotrexate must have been administered before surgery 4. Recovery from prior therapy allowing administration of chemotherapy 5. No progression of metastatic disease or new metastatic disease 6. Macroscopically complete surgical resection of the primary tumor 7. In patients with metastatic disease, complete removal of all metastases or complete removal planned and deemed feasible 8. Age more than or equal to five for patients with good response 9. Essential data collection will be provided 10. Written consent to undergo randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Added as of 10/09/2008: Event-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 10/09/2008: 1. Overall survival 2. Toxicity as measured by CTCAE v3.0 3. Quality of life | — |
Countries
Austria, Belgium, Canada, Czech Republic, Finland, Ireland, New Zealand, Puerto Rico, Switzerland, United States of America
Outcome results
None listed