| Studiedesign |
Preoperative treatment
Methotrexate: 12 000 mg/m2, day 1, week 0, 1, 4 and 5
Cisplatin: 45 mg/m2/day x 2 days, week 2 and 6
Adriamycin: 75 mg/m2, day 1, week 2 and 6
Surgery week 9
Postoperative treatment – Good responders
Cisplatin: 45 mg/m2/day x 2 days, week 11, 15 and19
Adriamycin: 75 mg/m2, day 1, week 11, 15 and19
Methotrexate: 12 000 mg/m2, day 1, week 13, 14 17, 18,21 and 22
Postoperative treatment – Poor responders
Cisplatin: 45 mg/m2/day x 2 days, week 11, 15 and19
Adriamycin: 75 mg/m2, day 1, week 11, 15 and19
Methotrexate: 12 000 mg/m2, day 1, week 13, 14 17, 18,21 and 22
Ifosfamide: 2 000 mg/m2/day x 5 days, week 23, 26 and 29
|
| Endpoint(s) |
Primary
To increase the disease-free survival rate in patients with operable osteosarcoma as compared with the results of our previous osteosarcoma trial.
Secondary
1. To improve the effects of the preoperative treatment on the tumour.
2. To reduce long term toxicity such as impairment of heart function, hearing defects, and hypomagnesemia by shortening the total treatment time and the total accumulated total dose of the cytotoxic drugs. |