Clinical trial · Interventional
Targeted Oligometastatic Radiation in Pediatric and Young Adult Patients With Soft Tissue and Bone Sarcoma
NCT06796543CI-TRIAL-00117772TARGET-RTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Sarcoma | Sarcoma | CURATED_BROADER | 0.78 |
| Radiation Therapy Patient | — | UNRESOLVED | — |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Consolidative radiation therapy (cRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Consolidative radiation therapy (cRT)
- description
- 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.
- interventionNames
- Radiation: Consolidative radiation therapy (cRT)
- type
- NO_INTERVENTION
- label
- standard of care (SOC)
- description
- Patients in Stratum B will undergo standard of care (SOC) second line systemic therapy with radiation to at least one disease site.
Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 39 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.