Adult patients with soft tissue sarcoma are increasingly given adjuvant chemotherapy.
There is reason to believe that the effect of chemotherapy is most pronounced in patients with highly malignant tumors and SSG has therefore selected a high-risk group for a study protocol where adjuvant chemotherapy is involved.
Patients in the high-risk group is registered simultaneously prospectively in a phase 2 research study to compare survival results between chemotherapy-treated patients with matched historical controls. The high-risk group is selected according to age, histology, grade of malignancy, tumor size and localization as well as the presence of necrosis, vessel invasion and a diffuse infiltrative growth pattern.
The chemotherapy regimen consist of 6 courses of doxorubicin (60 mg/m2) and ifosfamide (6 g/m2), which are most effective drug treatment for soft tissua sarcoma. Patients ≥ 70: Doxorubicin (50 mg/m2) and ifosfamide (5 g/m2)
Patients with metastases are not appropriate for the research study.
Tumor with the following pathological findings:
- Infiltration of a blood vessel
- and/or two out of three of the following criteria:
- ≥ 8 cm
- infiltrating peripheral growth pattern
- tumor necrosis
- Age ≥ 18 and ≤ 75 years
- No serious internal medical disease
- Normal heart and lung function
- All high-grade malignant histological types except for intralesional osteosarcoma and chondrosarcoma, Ewing's, PNET, rhabdomyosarcoma, Kaposi's sarcoma, malignant mesenchynoma, clear cell sarcoma, alveolar soft tissue sarcoma, epithelioid sarcoma
- No metastases at the time of diagnosis
- Not treated for other non-metastatic cancer disease in the past five years. Patients with basal cell carcinoma of the skin or cervical cancer in situ may be included.
- No previous treatment with anthracyclines.
- Soft tissue sarcoma in extremity or trunk which fits into group A or B.