A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma
Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre, open label, randomized phase 3 selection study (1:2:2 randomization).
After confirmation of the eligibility criteria, 185 patients will be randomized 1:2:2 to
either the control arm (doxorubicin 60-75 mg/m² IV every 3 weeks) or experimental arm 1
(doxorubicin 12 mg/m2 IV every week) or experimental arm 2 (cyclophosphamide 100 mg orally BD
plus prednisolone 10-20 mg orally on day 1 to day 7 of each 14 day cycle).
HRQoL assessment will be performed every 3 weeks during the first 12 weeks and every 12 weeks
thereafter until month 12 after start of treatment.
Disease evaluation will be performed every 12 weeks until progression. The primary endpoint
of the study is difference among the study arms in physical and role functioning at 12 weeks.
Phase:
Phase 3
Details
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC