EUCTR2019-003543-30-SK
Active, not recruiting
Phase 1
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma (STRASS 2) - STRASS 2
European Organisation for Research and Treatment of Cancer0 sites250 target enrollmentJune 18, 2020
ConditionsPrimary high risk leiomyosarcoma or Liposarcoma ofretroperitoneal space or infra-peritoneal spaces of pelvisMedDRA version: 20.0Level: PTClassification code 10073135Term: Dedifferentiated liposarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10024189Term: LeiomyosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary high risk leiomyosarcoma or Liposarcoma ofretroperitoneal space or infra-peritoneal spaces of pelvis
- Sponsor
- European Organisation for Research and Treatment of Cancer
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven primary high risk leiomyosarcoma (LMS) or
- •Liposarcoma (LPS) of retroperitoneal space or infra\-peritoneal
- •spaces of pelvis.
- •\- LMS: Any grade and size \> 5 cm
- •\- LPS (diagnosis based on MDM2 and CDK4 expression on
- •IHC; additional proof of MDM2 amplification is highly
- •recommended but not mandatory):
- •\* Grade 3 DDLPS OR
- •\* Confirmed grade 2 DDLPS on biopsy only if:
- •FNCLCC score \= 5 AND clear necrosis on imaging (whether or not present on the biopsy. OR
Exclusion Criteria
- •Sarcoma originating from bone structure, abdominal or
- •gynecological viscera
- •Extension through the sciatic notch or across the diaphragm
- •Metastatic disease
- •Any previous surgery (excluding diagnostic biopsy), radiotherapy
- •or systemic therapy for the present tumour
- •Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any
- •of their metabolites or to any of their excipients
- •Congestive heart failure
- •Angina pectoris
Outcomes
Primary Outcomes
Not specified
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