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.
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
- 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.
2. Safety (Time Frame - 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
3. Limb Functionality (Time Frame - 2 years): as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS)
4. Quality of Life (Time Frame - 2 years): as measured by QLQ C30
IMRT/IGRT, Tumor resection, Brachytherapy: All:
Preoperative IMRT with small safety margins (GTV according to MRT plus 1.5cm laterally / 3cm proximodistally) to 50Gy total dose, 2 Gy single dose, 5 fractions per week, daily IGRT with in-room CT (Tomotherapy)
Tumor resection after 4-6 weeks
Stratum C: Interstitial Brachytherapy to tumor bed with 15 Gy total dose, 3 Gy single dose b.i.d. in second week after tumor resection
Quelle: ClinicalTrials.gov
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"Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins"
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