Randomised trial of single agent doxorubicin versus doxorubicin plus ifosfamide in the first line treatment of advanced or metastatic soft tissue sarcoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002113-36-SK

Enrollment

450

Registered

2006-06-15

Start date

2003-05-20

Completion date

Unknown

Last updated

2017-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic soft tissue sarcoma MedDRA version: 8.1 Level: HLGT Classification code 10041299

Interventions

Product Name: doxorubicin Pharmaceutical Form: Solution for injection Other descriptive name: doxorubicin Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -histological evidence of soft tissue sarcoma with advanced unresectable or metastatic disease -histological evidence of high-grade soft tissue sarcoma (grade 2-3) according to the FNLCC grading system -measurable lesion -WHO performance status 0 or 1 - ANC>= 2X10e9/l and platelets >=100x10e9/l Serum creatinine 120 mol/l or calculated clearance (Cockroft and Gault method) > 65 ml/min, two functioning kidneys Bilirubin 30 mol/l, Albumin > 25 g/l. -age between 18 and 60 years -written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -prior radiotherapy to the soleindex lesion available -prior chemotherapy for advanced or metastatic disease -other severe medical illness - GIST - mixed mesodermal tumour - Chondrosarcoma - malignant mesothelioma - neuroblastoma - osteosarcoma - Ewing's sarcoma / primitive neuroectodermal tumour - desmoplastic small round cell tumour - embryonal rhabdomyosarcoma - alveolar soft part sarcoma -symptomatic or known CNS metasases -prior or concurent second primary malignant tumors

Design outcomes

Primary

Measure	Time frame
Main Objective: Determine whether intensive combination chemotherapy with ifosfamide and doxorubicin is superior to doxorubicin alone in terms of overall survival;Secondary Objective: Secondary end-points will include response to treatment (RECIST criteria), toxicity (CTC version 2.0), and treatment related mortality;Primary end point(s): Overall survival	—

Countries

Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026