NCT06796543 Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
| NCT ID | NCT06796543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Metastatic Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-03-25 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-03-25 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Sahaja Acharya, MD
PRINCIPAL INVESTIGATOR
SKCCC Johns Hopkins Medical Institution
Frequently Asked Questions
Who can join the NCT06796543 clinical trial?
This trial is open to participants of all sexes, up to 39 Years, studying Metastatic Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796543 currently recruiting?
Yes, NCT06796543 is actively recruiting participants. Contact the research team at sachary7@jhmi.edu for enrollment information.
Where is the NCT06796543 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States, Minneapolis, United States.
Who is sponsoring the NCT06796543 clinical trial?
NCT06796543 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Sahaja Acharya, MD at SKCCC Johns Hopkins Medical Institution. The trial plans to enroll 70 participants.