No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 39
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
70 (estimated)
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Other
Who this trial is looking for
This trial is looking for children, adolescents, and young adults with soft tissue or bone sarcoma that has spread. Participants will receive targeted radiation therapy to improve their survival.
Are You a Good Fit for This Trial?
You may be able to join if
I am under 39 years old.
I have been diagnosed with soft tissue or bone sarcoma.
I have measurable metastatic disease.
My performance status score is 70 or greater.
You may not be able to join if
I have brain or spinal cord metastases.
I need emergency treatment for spinal cord compression.
I have non-measurable metastatic disease.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
Eligibility Criteria
Stratum A Inclusion Criteria:
* 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 molec…
Stratum A Inclusion Criteria:
* 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.
Stratum B Inclusion Criteria:
* Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1.
* Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age \< 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent).
* 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
* Radiation to at least one site is being recommended as part of second line therapy.
Stratum A Exclusion Criteria:
* 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.
* Pregnancy
Stratum B Exclusion Criteria:
* Brain or intracranial metastases, including leptomeningeal disease
* Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment
* Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions.
* Pregnancy
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