Status:
UNKNOWN
A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Scandinavian Sarcoma Group
Conditions:
Soft Tissue Sarcoma
Non Metastatic Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk tumors. SSG XX will...
Detailed Description
SSG XX, the third adjuvant STS protocol by SSG, is a phase II non-randomized trial in patients with high risk to develop metastases. SSG XX is based on a previous SSG trial (SSG XIII) regarding use of...
Eligibility Criteria
Inclusion
- Group A: Histological high-grade malignancy soft tissue sarcomas of the extremity and trunk wall.
- Patients fulfilling the high-risk criteria defined above (see detailed description) Group B: Patients with histological high-grade malignancy soft tissue sarcomas of the extremity and trunk wall for whom surgery carries an obvious risk of intralesional margin
- Other inclusion criteria for therapy group A and group B
- Age ≥ 18 y and ≤ 75 y
- WHO grade 0-1
- Adequate cardiac function (LVEF ≥ 50%)
- Normal GFR (clearance)
- Adequate haematologic and liver function
- All histotypes except those listed below
Exclusion
- The following histological types:
- Extraskeletal osteosarcoma and - chondrosarcoma, Ewing/PNET, rhabdomyosarcoma, Kaposi´s sarcoma, malignant mesenchymoma, clear cell sarcoma, alveolar soft part sarcoma, epithelioid sarcoma
- Radiation induced sarcoma
- No previous anthracycline treatment
- Less than 5 years free of another primary malignancy
- More than 12 weeks have elapsed since primary surgery (Group A)
- More than 4 weeks from diagnostic biopsy to start of chemotherapy (Group B)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00790244
Start Date
October 1 2007
End Date
October 1 2022
Last Update
July 6 2011
Active Locations (2)
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1
Scandinavian Sarcoma Group centers
Lund, Lund, Sweden, 221 85
2
Scandinavian Sarcoma Group Secretariat
Lund University Hospital, Lund, Sweden, SE-221 85