Neoplasms

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Quality of Life

Soft Tissue Sarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

60 to 75 mg/m² intravenous, every 3 weeks for max 6 cycles until PD

12 mg/m2 intravenous weekly for a maximum of 450 mg/m2 until PD

100 mg BD on day 1 to day 7 of each 14 day cycle until PD

Cyclophosphamide Oral Product

10-20 mg 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 for those Countries where Prednisolone in tablets is not available

Winette van der Graaf

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.

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

Difference in physical and role functioning at 12 weeks

tumor response according to RECIST criteria (version 1.1)

Progression-free-survival from the date of randomization to the date of first progression or death, whatever comes first

Overall survival from the date of randomization to the date of death, whatever the cause

European Organisation for Research and Treatment of Cancer - EORTC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma	NCT04780464	Advanced Soft-t...	Doxorubicin Doxorubicin Cyclophosphamid... Prednisolone Prednisone	65 Years -	European Organisation for Research and Treatment of Cancer - EORTC
A 3 Arm Randomized Study on Health-related QoL of Elderly Patients With Advanced Soft Tissue Sarcoma	NCT04780464	Advanced Soft-t...	Doxorubicin Doxorubicin Cyclophosphamid... Prednisolone Prednisone	65 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for cyclophosphamide oral product