Bone cancer Cancer Osteosarcoma
Conditions
Interventions
Patients are randomised to one of two treatment groups:
1. Group A: Two drug chemotherapy, cisplatin and adriamycin (doxorubicin) repeated every 3 weeks for three cycles. Surgery is recommended 3 we
Vincristine (V) 1.5 mg/m2 (max 2 mg) iv bolus day 1
adriamycin (A1) 25 mg/m2 iv bolus, days 1-3
(A2) 30 mg/m2, days 1, 2
bleomycin (B) 15 mg/m2
cyclophosphamide (C) 600 mg/m2, dactinomycin (D) 600 mg/m2
cisplatin (P) 120 mg/m2
VM weeks 0, 1, 5, 6, 12, 13, 17, 18
A1 weeks 2, 14
A2+P weeks 20, 23, 29, 32, 38, 41
BCD weeks 9, 26, 35. Surgery week 7.
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged <40 years 2. Biopsy proven osteosarcoma 3. Non-metastatic, untreated osteosarcoma of the long bones of an extremity 4. Normal cardiac, renal, hepatic, hematologic and pulmonary function prior to entry 5. Patients with parosteal, periosteal, pagetoid and post irradiation sarcoma or who have an inoperable tumour are excluded 6. No previous chemotherapy 7. No previous radiotherapy to the primary tumour 8. No medical contraindications to treatment
Exclusion criteria
Exclusion criteria: Not provided at time of registration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, relapse-free survival, response to pre-operative chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
United Kingdom
Outcome results
None listed