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

Phase 1

Conditions: ocally advanced or metastatic soft tissue sarcoma
MedDRA version: 8.1Level: HLGTClassification code 10041299

Registration Number: EUCTR2004-002113-36-SK

Lead Sponsor: European Organisation for the Research and Treatment of Cancer

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 450

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

-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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures