Stereotactic Radiation Therapy for Pediatric Sarcomas

NCT01763970 | Completed Results DMC

• 2 other identifiers: J1367NA_00070109
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Sarcoma; Metastatic Disease; Bony Sites

Keywords

Stereotactic; Radiotherapy; Hypofractionated

Outcome Measures

Primary Outcomes (1)

• Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled

  Local control was defined as the absence of local progression. Local progression was defined as: * (1) the development of a new soft tissue mass ≥1 cm at a site without a soft tissue component or with a soft tissue component \<1 cm in at baseline * (2) an increase in the largest axial dimension of the soft tissue component by \>20% in lesions with a ≥ 1 cm in soft tissue component at baseline * (3) a previous bone metastasis that was avid on fluorodeoxyglucose (FDG)-positron emission tomography (PET), became non-avid after SBRT, and then became avid again. The Kaplan-Meier method was used.

  6 months post-SBRT

Secondary Outcomes (5)

• Patient-specific Local Control at 6 Months Post-SBRT as Assessed by the Percentage of Patients Locally Controlled

  6 months post-SBRT

• Percentage of Patients With Progression-free Survival at 6 Months Post-SBRT

  6 months post-SBRT

• Percentage of Patients With Overall Survival at 6 Months Post-SBRT

  6 months post-SBRT

• Change in Quality of Life (QoL) as Assessed by the Brief Pain Inventory

  Baseline and one-month post-SBRT

• Number of Participants Experiencing Toxicity of SBRT

  12 months after treatment starts

Study Arms (1)

Hypofractionated SBRT

EXPERIMENTAL

800 cGy delivered in 5 fractions every day to total dose of 4000 cGy

Radiation: SBRT

Interventions

SBRT RADIATION

Also known as: Stereotactic Body Radiation Therapy (SBRT)

Hypofractionated SBRT

Eligibility Criteria

• Age: 4 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Sites (5)

Stanford Medical Center

Stanford, California, 94305-5847, United States

Location

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105-3678, United States

Location

MeSH Terms

Conditions

Sarcoma; Neoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Matthew Ladra,MD
• Organization: SKCCC at Johns Hopkins

mladra@jhmi.edu

(202) 537-4788

Study Officials

• Matthew Ladra, M.D.

  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: November 1, 2013
• Primary Completion: September 24, 2018
• Study Completion: April 1, 2020
• Last Updated: August 27, 2020
• Results First Posted: August 27, 2020

Record last verified: 2020-08

Locations

US (5)