Clinical trial · Interventional
Two Radiation Dose Schedules of SBRT to Lung Metastases < 5cm in Dimension
A Randomized Phase 2 Study of Two Radiation Dose Schedules of Stereotactic Body Radiotherapy (SBRT) to Lung Metastases < 5cm in Dimension
NCT03029416CI-TRIAL-00035285withdrawnPhase 2ClinicalTrials.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): PRMC Administrative Disapproval - Slow accrual
Summary
Brief summary (as posted)
30 Gy single fraction of SBRT for lung metastases will result in comparable oncologic outcomes to 18Gy in three fractions (or dosing to a BED \</-100Gy at the discretion of the radiation oncologist) with respect to disease control and toxicity.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Radiation Therapy Complication | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single Fraction of SBRT
- description
- Stereotactic Body Radiation Therapy delivered in a single session on one day
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
- type
- EXPERIMENTAL
- label
- Fractionated SBRT
- description
- Stereotactic Body Radiation Therapy delivered in three to five fractions with one fraction delivered every other day
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
- measure
- Local Disease Control Rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of malignant carcinoma/sarcoma (any site) with metastasis to lung. * Patients must not be eligible for therapy with curative intent (i.e. surgery, radiation, etc). * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * Age ≥18 years * ECOG performance status \>/= 2 (Karnofsky≥60%)). * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients with more than \>/=3 metastatic lung lesions or any one lesion greater than 5 cm. and/or extensive metastatic disease outside the chest. * Patients who are receiving any other investigational agents. * Patients with active systemic, pulmonary, or pericardial infection. * Pregnant or lactating women * Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Chemotherapy concurrent with SBRT is not allowed
References
Publications (0)
Data not yet available
No reference posted for this study.