About this trial

This study is designed for children, adolescents and young adults undergoing radiation therapy for metastatic sarcoma. The aim of the study is to investigate if the investigators can improve the overall survival of these patients by targeting metastatic sites with radiation.

Eligibility criteria

Qualifiers

Patients must be aged < 39 years at time of enrollment.

Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site.

Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 3mm with CT scan within 3 weeks from treatment start.

Disqualifiers

Brain or intracranial metastases, including leptomeningeal disease

Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment

Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present.

Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.

Trial design

Treatments tested in this trial

  • Consolidative radiation therapy (cRT)

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

3
Sibley Memorial Hospital20016, Washington D.C.District of Columbia, United States
Johns Hopkins Hospital21287, BaltimoreMaryland, United States
University of Minnesota55455, MinneapolisMinnesota, United States

Sponsors and collaborators

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Clark Charitable Foundation

Collaborator