AJCC Stage II and III, Soft Tissue Sarcoma of the Limb
Conditions
Keywords
Soft tissue sarcoma, Intensity-Modulated Radiation Therapy (IMRT), Tomotherapy, Safety Margins, Image-guided Radiation Therapy, Brachytherapy, interstitial
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.
Interventions
RADIATIONIMRT/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
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Complication Rate | 3 months | Wound Complication Rate up to 3 months after tumor resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Germany
Contacts
Primary ContactBarbara Röper, MD
Outcome results
None listed