Hypofractionated Stereotactic Radiation Therapy in Treating Younger Patients with Metastatic Sarcomas of Bony Sites

Status: Active

Description

This phase II trial studies how well hypofractionated stereotactic radiation therapy works in treating younger patients with sarcomas that have spread to other bony sites in the body. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

Eligibility Criteria

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed non-rhabdomyosarcoma of soft tissue or bone at any site
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan within 4 weeks of treatment start
  • Greatest tumor dimension of all sites must be =< 5.0 cm or < 250 cm^3
  • There is at least 1 metastatic site at one or more of the following sites: spine or non-spine bone and at maximum 5 sites can be treated on protocol
  • Surgically unresectable site as determined by tumor board or surgeon or patients who decline surgery
  • Life expectancy of at least 9 months
  • Lansky performance status >= 50
  • Ability to understand and the willingness to sign a written informed consent document and if a minor, have a guardian who meets the above criteria

Exclusion Criteria

  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to starting radiation treatment
  • Patients who have had any prior radiotherapy to the treatment site(s)
  • A patient may not participate in a concurrent treatment protocol; all patients will be eligible to receive chemotherapy alone, systemic therapeutic agents, or conventional chemo-radiotherapy at the time of clinical or radiographic disease progression or at 2 weeks following completion of SBRT
  • Pregnant women are excluded from this study
  • Refusal to take a pregnancy test prior to treatment if the patient is a woman with child bearing potential
  • Patients with a rhabdomyosarcoma will be excluded

Locations & Contacts

California

Palo Alto
Stanford Cancer Institute Palo Alto
Status: Approved
Contact: Iris Catrice Gibbs
Phone: 650-723-6171
Email: iris.gibbs@stanford.edu

District of Columbia

Washington
Sibley Memorial Hospital
Status: Active
Contact: Matthew Michael Ladra
Phone: 202-537-4787
Email: mladra@jhmi.edu

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: Active
Contact: Stephanie Alicia Terezakis
Phone: 443-287-7889
Email: stereza1@jhmi.edu

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Nadia Nicole Laack
Phone: 507-284-4561
Email: laack.nadia@mayo.edu

Tennessee

Memphis
St. Jude Children's Research Hospital
Status: Active
Contact: Matthew James Krasin
Phone: 901-595-3565
Email: matthew.krasin@stjude.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the lesion-specific local control at 6 months of stereotactic body radiation therapy (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 non-rhabdomyosarcoma soft tissue or bone sarcoma.

SECONDARY OBJECTIVES:

I. To describe the toxicity of SBRT delivered to a dose of 4000 cGy in 5 fractions of 800 cGy each for the population enrolled using grading with Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0.

II. To assess clinical response rate of each treated site by serial computed tomography (CT) assessment (fludeoxyglucose F 18 [FDG]-positron emission tomography [PET]/CT is optional for assessment).

III. To assess long-term clinical outcomes of this patient population after completion of SBRT by measuring relapse-free survival and overall survival.

IV. To assess quality of life following completion of SBRT using pre- and post-SBRT completion of the Brief Pain Inventory form and 10 point Visual Analog scale which will be filled out by the patient.

OUTLINE:

Patients undergo hypofractionated SBRT once daily for a total of 5 fractions. Treatment should be delivered as 5 consecutive days over 1 week, but may be delivered over 2 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then at 3, 6, 9, 12, 18, 24, 30, and 36 months.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Stephanie Alicia Terezakis

Trial IDs

Primary ID J1367
Secondary IDs NCI-2013-02433, NA_00070109
Clinicaltrials.gov ID NCT01763970