Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
- Conditions
- Soft Tissue Sarcoma of the LimbAJCC Stage II and III
- Interventions
- Radiation: IMRT/IGRT, Tumor resection, Brachytherapy
- Registration Number
- NCT01552239
- Lead Sponsor
- Technical University of Munich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
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
-
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
-
History of major wound complication or recurrent skin infection
-
Known HIV positivity
-
< 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
-
persisting acute toxicities > grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
-
Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
-
Prior radiotherapy to the site of present STS.
-
Chronic requirement for treatment with immuno¬suppressive agents or steroids.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Arm IMRT/IGRT, Tumor resection, Brachytherapy Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure
- Primary Outcome Measures
Name Time Method Wound Complication Rate 3 months Wound Complication Rate up to 3 months after tumor resection
- Secondary Outcome Measures
Name Time Method Efficacy 2 years Efficacy:
Rate of margin-free resection Local control rate (LC) Metastasis-Free Survival (MFS) Disease-Free Survival (DFS) Disease-Specific Survival, Overall Survival (OS) Limb Preservation Rate (LP)Safety 2 years Acute toxicity as measured by CTCAE v. 4.03 Late toxicity (skin, soft tissue, joint, bone, neural toxicity) as measured by CTCAE v. 4.03
Limb Functionality 2 years as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)
Quality of Life 2 years as measured by QLQ C30
Translational 2 years
Trial Locations
- Locations (1)
Klinikum rechts der Isar
🇩🇪Munich, Germany