Clinical trial · Interventional
(SBRT) and (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
Pilot Study Evaluating Stereotactic Body Radiation Therapy (SBRT) and Adaptive Radiation Therapy (ART) for Pulmonary Metastases From Soft Tissue Sarcomas
NCT01949506CI-TRIAL-00064290completedN/AResults postedClinicalTrials.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 is a prospective study to document the local control rates with SBRT specifically for pulmonary metastases from soft tissue sarcoma. This study will prospectively document acute and late toxicity, quality of life (QoL), tumor control, and survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma,Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
| Stage IV Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Stereotactic Body Radiation Therapy
- description
- Arms: Stereotactic Body Radiation Therapy (SBRT) with Adaptive Radiation Therapy (ART) for all patients. A non-randomized study. Patients must have 1-5 pulmonary metastases all less than 5 cm in size. Pathologic confirmation of primary soft tissue sarcoma. All lesions to receive 3-5 fractions to each tumor. Treatments delivered with \> 10 Gy per fraction will have a minimum of 48 hour interfraction interval. For treatments with ≤ 10 Gy per fraction will have a minimum 24 hour interfraction interval. Treatments will be ideally completed over 14 days for 3 fraction treatments and over 21 days for \>5 fraction treatment schedules.
- interventionNames
- Radiation: SBRT
Primary outcomes (1)
- measure
- Number of Adverse Events of Grade ≥ 3 by CTCAE Criteria.
- timeFrame
- 6 weeks post SBRT
- description
- This measure (number of adverse events of grade ≥ 3 by Common Terminology Criteria for Adverse Events (CTCAE) criteria) will provide information regarding the acute toxicity of SBRT for \< 5 pulmonary metastases from soft tissue sarcoma..The CTCAE criteria provide a standardized description of adverse events including guidelines for grading severity. The guidelines can be viewed at: https://ctep.cancer.gov/protocoldevelopment/electronic\_applications/ctc.htm.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * Pathologic confirmation of primary soft tissue sarcoma with pathologic or radiographic evidence of pulmonary metastatic disease * No evidence of extra pulmonary progression of disease for 3 months prior to enrollment on study * 1-5 pulmonary lesions all ≤5 cm in size * Medically inoperable or declines surgery * Patients may have had previous treatment for pulmonary metastases Exclusion Criteria: * Patients who have uncontrolled extra-pulmonary disease * Pregnant women * Patients who have greater than 5 pulmonary lesions at the time of study enrollment * Patients who have disease progression outside the lungs within 3 months of enrollment on the study * Disease pathology other than sarcoma subtypes * Patients with a history of metastatic disease from a primary other than sarcoma
References
Publications (0)
Data not yet available
No reference posted for this study.