Neoadjuvant treatment in high risk superficial soft tissue sarcomas of limbs and soft tissue of the trunk phase II study - STM001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001425-25-IT

Enrollment

Registered

2006-04-07

Start date

2006-05-03

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Patients with high risk primary or recurrent soft tissue sarcoma MedDRA version: 6.1 Level: HLGT Classification code 10041299

Interventions

Trade Name: FARMORUBICINA IV 1FL 50MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Epirubicin CAS Number: 56390-09-1 Concentration unit: mg milligram(s) Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: a Evidence of distant metastases b Prior radio or chemotherapy c Pregnancy or breast feeding d Concomitant neoplasm e Mental disorders

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

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