Stereotactic Radiation Therapy for Pediatric Sarcomas
Condition: Sarcoma; Metastatic Disease; Bony Sites
MeSH terms: Sarcoma; Neoplasm Metastasis
Study type: Interventional

Summary: 
      The stereotactic body radiation therapy (SBRT) literature focuses on clinical outcomes in the
      adult population. However, SBRT has a particularly strong rationale for application in
      pediatrics given that high biologically effective doses have been shown to increase control
      in histologies, such as sarcoma, which are common in the pediatrics population. With
      stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the
      target lesion of interest may also be accomplished resulting in lower toxicity. Given that
      pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are
      still considered to be a curable population with aggressive local therapy, SBRT could have a
      significant impact on outcomes in oligometastatic patients who may be otherwise unresectable.
    

Detailed description: 
      Pediatric patients with sarcoma who have limited metastases are still potentially curable
      with aggressive local therapy. However, conventional moderate dose radiation is unlikely to
      provide durable local control. Given the recent technologic advances in radiation delivery,
      it is now possible to deliver tumoricidal doses, using stereotactic radiation over a short
      time course with highly focal techniques. Stereotactic radiation has proven efficacious in
      the intracranial setting and in multiple extracranial sites in adults. It has not yet been
      well studied in the pediatrics population where there is a particularly strong rationale due
      to the ablative doses that can be delivered to tumor while simultaneously reducing high dose
      to normal tissues. The proposed trial is a single arm phase II study to determine the
      efficacy of SBRT in pediatric sarcomas with surgically unresectable metastatic disease.
      Oligometastatic sites eligible for treatment in this study include bony sites of disease.
      SBRT will be delivered to each eligible site to a total dose of 4000 delivered in 5 fractions
      of 800 per fractions each day. Following completion of SBRT, patients will undergo treatment
      response assessment with the use of diagnostic imaging, clinical examination, and completion
      of the Brief Pain Inventory to assess quality of life. The primary objective of this study is
      to determine the efficacy of SBRT delivered to a dose of 4000 centigray (cGy) in 5 fractions
      of 800 cGy each for patients greater than 3 years of age and < 40 years of age with
      metastatic disease of bone secondary to pediatric sarcoma. The secondary objectives of this
      study include describing the toxicity of SBRT with this regimen; assessing clinical response
      rate of each target lesion; assessing long-term clinical outcomes; and assessing quality of
      life following completion of treatment. For patients with potentially curable oligometastatic
      disease, surgical resection in conjunction with systemic therapy remains the standard of
      care. Patients on this study will continue to receive chemotherapy outside of the 2 week
      window for SBRT. Issues that may limit participation include our inability to assess late
      effects that may not develop till at least 10 years after therapy. For this reason, we will
      limit the population in this study to patients who are surgically unresectable and would be
      otherwise incurable with current standard systemic therapies.
    

Intervention name(s): SBRT
Intervention type(s): Radiation
Other intervention name(s): Stereotactic Body Radiation Therapy (SBRT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stereotactic; Radiotherapy; Hypofractionated