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Stereotactic Radiation Therapy for Pediatric Sarcomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01763970
First received: January 7, 2013
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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).


Condition Intervention Phase
Sarcoma
Metastatic Disease
Bony Sites
Radiation: SBRT
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Hyperfractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • SBRT Efficacy [ Time Frame: for the first year after treatment starts ] [ Designated as safety issue: Yes ]
    To determine the efficacy of SBRT delivered to a dose of 4000 in 5 fractions of 800 each for patients greater than 3 years of age and < 40 years of age with metastatic disease of bone secondary to pediatric sarcoma


Secondary Outcome Measures:
  • Toxicity of SBRT [ Time Frame: for the first year after treatment starts ] [ Designated as safety issue: Yes ]
    To describe the toxicity of SBRT delivered to a dose of 4000 in 5 fractions for patients with sarcomas greater than 3 years of age and < 40 years of age with metastatic disease.

  • Response rate [ Time Frame: 6 months after treatment has started ] [ Designated as safety issue: Yes ]
    To assess clinical response rate of each target lesion

  • Long-term clinical outcomes [ Time Frame: for the first year after treatment starts ] [ Designated as safety issue: Yes ]
    To assess long-term clinical outcomes of this patient population after completion of SBRT

  • Quality of Life (QoL) [ Time Frame: for the first year after treatment starts ] [ Designated as safety issue: No ]
    To assess quality of life following completion of SBRT


Estimated Enrollment: 20
Study Start Date: November 2013
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypofractionated SBRT
800 delivered in 5 fractions every day to total dose of 4000
Radiation: SBRT
800 delivered in 5 fractions every day to total dose of 4000
Other Name: Stereotactic Body Radiation Therapy (SBRT)

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 in 5 fractions of 800 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.

  Eligibility

Ages Eligible for Study:   4 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763970

Contacts
Contact: Stephanie Terezakis, M.D. 443-287-7889 sterezak@jhmi.edu
Contact: Kelly Szajna, R.N. 410-502-9242 kszajna1@jhmi.edu

Locations
United States, California
Stanford Medical Center Not yet recruiting
Stanford, California, United States
Contact: Iris Gibbs, MD    650-736-1480    iris.gibbs@stanford.edu   
Contact: Alice Bahn       aliceb@stanford.edu   
Principal Investigator: Iris Gibbs, MD         
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Stephanie Terezakis, M.D.    443-287-7889    sterezak@jhmi.edu   
Contact: Kelly Szajna, R.N.    410-614-3950    kszajna1@jhmi.edu   
Sub-Investigator: David Loeb, M.D.         
Sub-Investigator: Steve Cho, M.D.         
Sub-Investigator: Deborah Frassica, M.D.         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States
Contact: Nadia Laack, MD    507-284-4561    Laack.Nadia@mayo.edu   
Contact: Geri Pumper    507-293-2842    pumper.geralyn@mayo.edu   
Principal Investigator: Nadia Laack, MD         
United States, Tennessee
St. Jude Hospital Not yet recruiting
Memphis, Tennessee, United States
Contact: Matthew Krasin, MD    901-595-3565    matthew.krasin@stjude.org   
Contact: Meghan Brown       Meghan.Brown@STJUDE.ORG   
Principal Investigator: Matthew Krasin, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Stephanie Terezakis, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01763970     History of Changes
Other Study ID Numbers: J1367, NA_00070109
Study First Received: January 7, 2013
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Stereotactic
Radiotherapy
Hypofractionated

Additional relevant MeSH terms:
Sarcoma
Neoplasm Metastasis
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014