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.
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.
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.
Parallel
Consolidative radiation therapy (cRT)
RadiationTreatment that is given after cancer has disappeared following the initial therapy. Consolidation therapy is used to kill any cancer cells that may be left in the body. It may include radiation therapy, a stem cell transplant, or treatment with drugs that kill cancer cells. Also called intensification therapy and postremission therapy.
Event free survival
2-year event free survival (EFS1) after cRT in patients with oligometastatic sarcoma as compared to historical control (applies to newly diagnosed (Stratum A) patients.
Overall survival (OS)
2-year overall survival (OS) after cRT (applies to newly diagnosed (Stratum A) patients)
Overall Survival (OS) and Event Free Survival (EFS1), stratified by sarcoma histology
To determine differences in overall survival (OS) and event free survival (EFS1) after cRT between EWS, RMS and other sarcoma histologies (applies to newly diagnosed (Stratum A) patients.
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Clark Charitable Foundation
Collaborator
