Clinical trial · Interventional
Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors
NCT02581384CI-TRIAL-00051542terminatedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study closed primarily due to weak accrual, as well as study design limitations.
Summary
Brief summary (as posted)
This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nos | Soft Tissue Sarcoma | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Renal Tumor | Kidney Neoplasm | ALIAS | 0.90 |
| Rhabdoid Tumor | Rhabdoid Tumor | ONTOLOGY_EXACT | 0.98 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Sarcoma, Ewing | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Cohort 1 Dose Level 1 [Phase I]
- description
- Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
- type
- EXPERIMENTAL
- label
- Cohort 1 Dose Level 2 [Phase I]
- description
- Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.
- interventionNames
- Radiation: Stereotactic Body Radiotherapy (SBRT)
- type
- EXPERIMENTAL
- label
- Cohort 1 Dose Level 3 [Phase I]
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid) * Age ≤ 21 years; * Must be capable of treatment without general anesthesia * Lesion size 8 mm - 3 cm * Subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis * Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present * Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin * Informed consent/assent * Life expectancy \>3 months * Pulmonary Function FEV1 ≥ 50% of predicted; * Concurrent immunotherapy is allowed Exclusion Criteria: * Prior whole-lung or hemi-thorax irradiation of greater than 12 Gy received less than 6 months prior to consent (focal radiotherapy to the thorax is not an exclusion) * Lesion larger than 3 cm in diameter * Patients for whom surgery would be deemed appropriate rather than radiotherapy
References
Publications (1)
- RESULTLiu KX, Chen YH, Kozono D, Mak RH, Boyle PJ, Janeway KA, Mullen EA, Marcus KJ. Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. Adv Radiat Oncol. 2020 Sep 23;5(6):1267-1273. doi: 10.1016/j.adro.2020.09.004. eCollection 2020 Nov-Dec. PMID 33305087