SBRT1: Stereotactic Radiation Therapy for Pediatric Sarcomas

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

Categories:

Radiology

Phase I/II

Solid Tumor

Diseases Treated:

Metastatic sarcomas

Eligibility Overview:

  • Participant has histologically or cytologically confirmed diagnosis:
    • Nonrhabdomyosarcoma of soft tissue
    • Ewing sarcoma
    • Osteosarcoma at any site
  • Participant must be greater than 3 years of age and < 40 years of age.
  • Participant has not had any prior radiotherapy to the treatment site.

Description

This is a phase II study to determine the efficacy of stereotactic body radiotherapy (SBRT) in pediatric sarcomas with surgically unresectable bony metastatic disease. This research is being done to learn if a type of radiation called stereotactic body radiation (SBRT) can effectively treat children who have sarcomas that have spread to the bone and cannot be removed with surgery.

Stereotactic radiation is a very focused and precise type of radiation. A higher dose of radiation is given at every treatment over a fewer number of days than standard radiation treatment. Standard radiation delivers less dose of radiation every day over a longer period of time and is delivered with a different technique that generally treats a larger area in the body.

We know that stereotactic radiation can stop sarcomas from growing in adults. This study is being done to learn if this type of radiation can also stop sarcomas from growing in children. With stereotactic radiation, we hope to increase the radiation dose to the tumor and decrease the amount of area treated with radiation.

SBRT will be performed over 5 days. After SBRT, participants will undergo follow up including diagnostic imaging, clinical examination, and completion of a questionnaire to assess Quality of Life.

Objectives

Primary Objective

  • To determine the lesion-specific local control at 6 months of SBRT delivered to a dose of 4000 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

  • 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 CTCAE v. 4.0
  • To assess clinical response rate of each treated site by serial CT assessment (FDG- PET/CT is optional for assessment)
  • To assess long-term clinical outcomes of this patient population after completion of SBRT by measuring relapse-free survival and overall survival
  • 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 participant.

Eligibility criteria, among others, include:

  • Participant has histologically or cytologically confirmed diagnosis:
    • Nonrhabdomyosarcoma of soft tissue
    • Ewing sarcoma
    • Osteosarcoma at any site
  • Participant must be greater than 3 years of age and < 40 years of age.
  • Participant has not had any prior radiotherapy to the treatment site.
  • Participant’s life expectancy of at least 9 months.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Matthew Krasin, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.