Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
TARGET-RT
2 other identifiers
interventional
70
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2025
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
April 20, 2026
April 1, 2026
2.9 years
January 22, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (2)
Overall survival (OS)
2 years
Overall Survival (OS) and Event Free Survival (EFS1), stratified by sarcoma histology
2 years
Study Arms (2)
Consolidative radiation therapy (cRT)
EXPERIMENTALThe therapeutic intervention in Stratum A is consolidative radiation therapy (cRT), which is defined as radiation/surgery to the primary site and radiation to all sites of metastatic disease. All patients enrolled in stratum A will receive standard of care (SOC) induction chemotherapy followed by restaging imaging prior to delivery of cRT.
standard of care (SOC)
NO INTERVENTIONPatients in Stratum B will undergo standard of care (SOC) second line systemic therapy with radiation to at least one disease site.
Interventions
Treatment 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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify 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 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
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sahaja Acharya, MD
SKCCC Johns Hopkins Medical Institution
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2025
First Posted
January 28, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2030
Last Updated
April 20, 2026
Record last verified: 2026-04