NCT04780464

A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma

a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Every Three Weeks or Doxorubicin Weekly or Cyclophosphamide Plus Predniso(lo)ne Treatment

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Doxorubicin	60 to 75 mg/m² intravenous, every 3 weeks for max 6 cycles until PD
DRUG	Doxorubicin	12 mg/m2 intravenous weekly for a maximum of 450 mg/m2 until PD
DRUG	Cyclophosphamide Oral Product	100 mg BD on day 1 to day 7 of each 14 day cycle until PD
DRUG	Prednisolone	10-20 mg on day 1 to day 7 of each 14 day cycle until PD
DRUG	Prednisone	10-20 mg on day 1 to day 7 of each 14 day cycle until PD for those Countries where Prednisolone in tablets is not available

Timeline

• Start date: 2022-04-11
• Primary completion: 2023-09-22
• Completion: 2023-11-11
• First posted: 2021-03-03
• Last updated: 2024-02-22

Locations

2 sites across 2 countries: Cyprus, Jordan