Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
- Compare the progression-free and overall survival of patients with locally advanced or
metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and
pegfilgrastim as first-line therapy.
- Compare the response in patients treated with these regimens.
- Compare the treatment-related mortality of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50
years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs
3), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).
- Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on
days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression and then every 12 weeks
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Ian R. Judson, MA, MD, FRCP
Institute of Cancer Research, United Kingdom
United States: Federal Government