Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 39
Healthy Volunteers: f
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• 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.

Locations
United States
Washington, D.c.
Sibley Memorial Hospital
RECRUITING
Washington D.c.
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Sahaja Acharya, MD
sachary7@jhmi.edu
4432877889
Backup
Ethan Arnone, BS
earnone3@jh.edu
2029192533
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2030-03
Participants
Target number of participants: 70
Treatments
Experimental: Consolidative radiation therapy (cRT)
The 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.
No_intervention: standard of care (SOC)
Patients in Stratum B will undergo standard of care (SOC) second line systemic therapy with radiation to at least one disease site.
Sponsors
Collaborators: Clark Charitable Foundation
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov