Stereotactic Radiation Therapy for Pediatric Sarcomas

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 14-003460
    NCT ID: NCT01763970
    Sponsor Protocol Number: 14-003460

About this study

The SBRT (stereotactic body radiation therapy) literature focuses on clinical outcomes in the adult population. However, SBRT (stereotactic body radiation therapy) 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 (11,25). 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 (25-28).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • confirmed sarcoma of the soft tissue or bone
  • must have measurable disease via CT scan
  • tumor malignancies must meet certain criteria to be eligible
  • 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
  • ability to understand and willingness to sign informed consent document

Exclusion Criteria:

  • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nadia Laack, M.D.

Open for enrollment

Contact information:

Diane Vogen

(507)293-0621

Vogen.Diane2@mayo.edu

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CLS-20204242

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