Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bon… (NCT06796543) | Clinical Trial Compass
RecruitingNot Applicable
Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
United States70 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range39 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Cl…
What they're measuring
1
Event free survival
Timeframe: 2 years
Trial details
NCT IDNCT06796543
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins