NCT01552239
Unknown
Phase 2
Phase II Study of Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance, Small Safety-margins and Brachytherapy Conditioned by Resection Margin
Technical University of Munich1 site in 1 country50 target enrollmentAugust 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Soft Tissue Sarcoma of the Limb
- Sponsor
- Technical University of Munich
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Wound Complication Rate
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.
PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:
- •Lesion originates in extremity
- •upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
- •lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
- •AJCC Stage II or III disease (except T1a-tumors or N1)
- •Primary presentation or local recurrence
- •after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
- •Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
- •ECOG Performance Status 0-2
- •Informed Consent
Exclusion Criteria
- •Diagnosis of the following:
- •Primitive neuroectodermal tumor
- •Soft tissue Ewing's sarcoma
- •Extraskeletal osteo- or chondrosarcoma
- •Aggressive fibromatosis (desmoid tumors)
- •Dermatofibrosarcoma protuberans
- •Regional nodal disease or unequivocal distant metastasis
- •Life expectancy \< 1 year
- •Pregnancy
- •Major medical illness that would preclude study treatment
Outcomes
Primary Outcomes
Wound Complication Rate
Time Frame: 3 months
Wound Complication Rate up to 3 months after tumor resection
Secondary Outcomes
- Efficacy(2 years)
- Safety(2 years)
- Limb Functionality(2 years)
- Quality of Life(2 years)
- Translational(2 years)
Study Sites (1)
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