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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma of the Limb,, AJCC Stage II and III

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Wound Complication Rate

Outcome Description:

Wound Complication Rate up to 3 months after tumor resection

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Barbara Röper, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinik für Strahlentherapie und Radiologische Onkologie

Authority:

Germany: Ethics Commission

Study ID:

PRE-1205-ROE-0050-I

NCT ID:

NCT01552239

Start Date:

August 2011

Completion Date:

October 2017

Related Keywords:

  • Soft Tissue Sarcoma of the Limb,
  • AJCC Stage II and III
  • Soft tissue sarcoma
  • Intensity-Modulated Radiation Therapy (IMRT)
  • Tomotherapy
  • Safety Margins
  • Image-guided Radiation Therapy
  • Brachytherapy
  • interstitial
  • Sarcoma

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