A randomised trial of the European and American Osteosarcoma Study group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy - Euramos 1
- Conditions
- Osteosarcoma
- Registration Number
- EUCTR2004-000242-20-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1400
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 < 16).
11. Patient fit to undergo protocol treatment and follow-up
12. Written informed consent.
Randomization
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 = 5 for patients with good response
9. Written consent to undergo randomization.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Registration:
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal 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.;Secondary Objective: 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.
- Secondary Outcome Measures
Name Time Method