A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma (Tolerance)
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|ClinicalTrials.gov Identifier: NCT04780464|
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Soft-tissue Sarcoma||Drug: Doxorubicin Drug: Cyclophosphamide Oral Product Drug: Prednisolone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||a 3 Arm Randomized Study on Health-related Quality of Life of Elderly Patients With Advanced Soft Tissue Sarcoma Undergoing Doxorubicin Alone Three Weekly or Doxorubicin Weekly or Cyclophosphamide Plus Prednisolone Treatment|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||June 1, 2025|
|Estimated Study Completion Date :||March 1, 2027|
|Active Comparator: Standard doxorubicin||
60 to 75 mg/m² intravenous, every 3 weeks for max 6 cycles until PD
Other Name: Adriamycin;
|Experimental: Metronomic doxorubicin||
12 mg/m2 intravenous weekly for a maximum of 450 mg/m2 until PD
Other Name: Adriamycin;
|Experimental: Metronomic oral cyclophosphamide + prednisolone||
Drug: Cyclophosphamide Oral Product
100 mg BD on day 1 to day 7 of each 14 day cycle until PD
10-20 mg on day 1 to day 7 of each 14 day cycle until PD
- Health-related Quality of Life [ Time Frame: 4 years after first patient in ]Difference in physical and role functioning at 12 weeks
- Tumour response [ Time Frame: 5.5 years after first patient in ]tumor response according to RECIST criteria (version 1.1)
- Progression-free-survival [ Time Frame: 5.5 years after first patient in ]Progression-free-survival from the date of randomization to the date of first progression or death, whatever comes first
- Overall survival [ Time Frame: 5.5 years after first patient in ]Overall survival from the date of randomization to the date of death, whatever the cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780464
|Contact: EORTC HQ||+32 2 774 email@example.com|
|Study Chair:||Winette van der Graaf||Nationaal Kanker Instituut, Amsterdam, NL|