Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins (PREMISS)

Technical University of Munich

Status and phase: Unknown; Phase 2

Conditions: AJCC Stage II and III; Soft Tissue Sarcoma of the Limb

Treatments: Radiation: IMRT/IGRT, Tumor resection, Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01552239

PRE-1205-ROE-0050-I

No. 2009.906.1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

1 Arm

Experimental group

Description:

Stratum A: R0, primary wound closure Stratum B: R0, secondary wound closure Stratum C: R1, tertiary wound closure

Treatment:

Radiation: IMRT/IGRT, Tumor resection, Brachytherapy