Clinical trial NCT01552239: Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
Official 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Soft Tissue Sarcoma of the Limb
AJCC Stage II and III
Keywords: Soft tissue sarcoma
Intensity-Modulated Radiation Therapy (IMRT)
Tomotherapy
Safety Margins
Image-guided Radiation Therapy
Brachytherapy
interstitial
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-03-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Wound Complication Rate
timeFrame: 3 months
Secondary outcomes:
measure: Efficacy
timeFrame: 2 years
measure: Safety
timeFrame: 2 years
measure: Limb Functionality
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Translational
timeFrame: 2 years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
Study officials:
affiliation: Klinik für Strahlentherapie und Radiologische Onkologie
name: Barbara Röper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.