eoadjuvant treatment in high risk superficial soft tissue sarcomas of limbs and soft tissue of the trunk phase II study - STM001
- Conditions
- Patients with high risk primary or recurrent soft tissue sarcomaMedDRA version: 6.1Level: HLGTClassification code 10041299
- Registration Number
- EUCTR2006-001425-25-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 42
a Histologically confirmed diagnosis of primary pr relapsed adult soft tissue sarcomas b Histological grade 3 or 2 with necrosis 8805; 50 FNCC classification b Primary site limbs, pelvis, c Superficial site trunk d Dimension 8805; 5 cm evaluated by CT scan or MR e Age 18 - 65 years f Performance status according to ECOG 8804; 1 g Adequate bone marrow function WBC 8805; 3.000/mm3, neutrophyl 8805; 1.500/mm3, platelets 8805; 100.000/mm3, hemoglobin 8805; 10g h Adequate renal and hepatic function i Normal cardiac function LVEF 8805; 50 j 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) yes
F.1.3.1 Number of subjects for this age range
a Evidence of distant metastases b Prior radio or chemotherapy c Pregnancy or breast feeding d Concomitant neoplasm e Mental disorders
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Disease-free survival;Secondary Objective: Clinical and pathological responses. Toxicity evaluation Overall survival Numbers of conservative surgery;Primary end point(s): Disease free survival
- Secondary Outcome Measures
Name Time Method