Stereotactic Radiation Therapy for Pediatric Sarcomas

Trial ID or NCT#

NCT01763970

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

A Phase II Study of Hyperfractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites

Eligibility Criteria

Ages Eligible for Study: 4 Years to 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - histologically or cytologically confirmed metastatic sarcoma of the soft tissue or bone - must have measurable disease - disease must be surgically unresectable as determined by a tumor board or surgeon - greater than 3 years of age - less than or equal to 40 years of age - life expectancy of at least 9 months - adequate performance status (Lansky Performance Status greater than or equal to 50). - ability to understand and willingness to sign informed consent document
Exclusion Criteria:
  1. - patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study - patients who have had any prior radiotherapy to the treatment site(s) - patients may not participate on any other treatment protocol while they are receiving treatment on this protocol and for up to 3 months after these protocol treatments have ended - pregnant women - refusal of women of child bearing potential to take a pregnancy test prior to treatment

Investigator(s)

Iris C. Gibbs, MD, FACR, FASTRO
Iris C. Gibbs, MD, FACR, FASTRO
Radiation oncologist, Neuro-oncologist
Professor of Radiation Oncology (Radiation Therapy) and, by courtesy, of Neurosurgery

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Contact

Iris Gibbs, MD
650-736-1480