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| ID | Type | Description | Link |
|---|---|---|---|
| No. 2009.906.1 | Other Grant/Funding Number | Wilhelm-Sander-Stiftung |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Arm | Experimental | Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT/IGRT, Tumor resection, Brachytherapy | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Complication Rate | Wound Complication Rate up to 3 months after tumor resection | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 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) | 2 years |
| Safety |
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Inclusion Criteria:
Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:
Lesion originates in extremity
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Röper, MD | Contact | +49-89-4140 | 4509 | barbara.roeper@lrz.tu-muenchen.de |
| Name | Affiliation | Role |
|---|---|---|
| Barbara Röper, MD | Klinik fĂ¼r Strahlentherapie und Radiologische Onkologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum rechts der Isar | Recruiting | Munich | 81675 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26573139 | Derived | Roper B, Heinrich C, Kehl V, Rechl H, Specht K, Wortler K, Topfer A, Molls M, Kampfer S, von Eisenharth-Rothe R, Combs SE. Study of Preoperative Radiotherapy for Sarcomas of the Extremities with Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS). BMC Cancer. 2015 Nov 16;15:904. doi: 10.1186/s12885-015-1633-y. |
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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
| 2 years |
| Limb Functionality | as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS) | 2 years |
| Quality of Life | as measured by QLQ C30 | 2 years |
| Translational | 2 years |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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