Clinical trial · Interventional
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AJCC Stage II and III | — | UNRESOLVED | — |
| Soft Tissue Sarcoma of the Limb | Sarcoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT/IGRT, Tumor resection, Brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1 Arm
- description
- Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure
- interventionNames
- Radiation: IMRT/IGRT, Tumor resection, Brachytherapy
Primary outcomes (1)
- measure
- Wound Complication Rate
- timeFrame
- 3 months
- description
- Wound Complication Rate up to 3 months after tumor resection
Secondary outcomes (5)
- measure
- Efficacy
- timeFrame
- 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRoper 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. PMID 26573139