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New treatment option for Metastatic Sarcoma
Official title Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
ClinicalTrials.gov ID: NCT06796543
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 39
You may be able to join if
- Stratum A
- 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...
You likely can't join if
- 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...
- Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or...
- Pregnancy Stratum B Exclusion Criteria:
- Brain or intracranial metastases, including leptomeningeal disease
See the full eligibility criteria
- Stratum A
- 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...
- 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...
- 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...
- Radiation to at least one site is being recommended as part of second line therapy. Stratum A
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.