SSG XIV
Titel

A Scandinavian treatment research protocol for extremity localized high-grade osteosarcoma.

Akronym
SSG XIV
Typ av studie Non-randomized phase II multicenter phase II  study
Sponsor Scandinavian Sarcoma Group (SSG)
Inklusionskriterier
  • Age <40 years.
  • Histologically proven extremity localized osteosarcoma
    of high-grade malignancy (grade III or IV).
  • The diagnosis must be made by open or coarse needle biopsy.
  • The tumour must arise in the marrow or at the bone surface.
  • Only patients with localized disease are eligible. The use of CT scan of the chest and total bone scan is mandatory to exclude metastases.
  • No previous treatment should have been given for osteosarcoma.
  • Adequate bone marrow,  hepatic and renal function.
  • Chemotherapy must be started within four weeks after the histological diagnosis.
  • Patient registration form must be accompanied by representative histology slides (for verification of diagnosis) and conventional anterior/posterior and lateral X-rays of the entire involved bone (for estimation of tumour volume).
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.

Rekryteringsperiod

2001-2005

Antal inkluderade patienter

73

Publikationer

Under preparation

   
pil Tillbaka till Kliniska prövninga

Uppdaterad: 2000 03 17