Clinical trial · Interventional
Study on SBRT for Inoperable Lung and Liver Oligometastases From Breast Cancer
Prospective Non-randomized Phase II Study on Stereotactic Body Radiation Therapy for Medically Inoperable Lung and Liver Oligometastases From Breast Cancer
NCT02581670CI-TRIAL-00058234unknownN/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)
Investigators designed a phase II study to evaluate safety and efficacy of lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastasis to Liver | — | UNRESOLVED | — |
| Metastasis to Lung | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic radiation therapy (SRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oligometastatic breast cancer patients
- description
- Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients medically inoperable, using VMAT RapidArc approach.
- interventionNames
- Radiation: stereotactic radiation therapy (SRT)
Primary outcomes (2)
- measure
- Toxicity in oligometastatic breast cancer patients monitoring using CTCAE v.4
- timeFrame
- 3 years
- measure
- Local control of disease after SBRT according to EORTC questionnaire
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \>18 years with ECOG 0-2 * Diagnosis of Breast Cancer * DFI (Disease-free interval) \> 1 year * No extrapulmonary and/or extrahepatic disease or other metastatic sites stable or responding after chemotherapy * No life threatening conditions * Lung and liver lesions \< 5 (with maximum diameter \< 5 cm) * Chemotherapy completed at least 3 weeks before treatment * Chemotherapy started at least 2 weeks after treatment allowed * Systemic therapies other than chemotherapy allowed (i.e hormonal therapies and/or immunotherapy) * Written informed consent Exclusion Criteria: * ECOG \> 2 * Pregnant women * Patients with inability to consent
References
Publications (0)
Data not yet available
No reference posted for this study.