AJCC Stage II and III Clinical Trial
— PREMISSOfficial title:
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
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | October 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Klinikum rechts der Isar | Munich |
| Lead Sponsor | Collaborator |
|---|---|
| Technische Universität München |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Wound Complication Rate | Wound Complication Rate up to 3 months after tumor resection | 3 months | |
| Secondary | 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 | |
| Secondary | Safety | 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 | |
| Secondary | Limb Functionality | as measured by the Musculoskeletal Tumor Society (MSTS) rating scale and the Toronto Extremity Salvage Score (TESS) | 2 years | |
| Secondary | Quality of Life | as measured by QLQ C30 | 2 years | |
| Secondary | Translational | 2 years |