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

NCT04780464 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-02-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Winette van der Graaf · Nationaal Kanker Instituut, Amsterdam, NL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-11
Primary Completion
2023-09-22
Completion
2023-11-11

Countries

  • Cyprus
  • Jordan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780464 on ClinicalTrials.gov