Clinical trial · Interventional
Fractionated Stereotactic Radiotherapy for Limited Small Volume Brain Metastases
Fractionated Stereotactic Radiotherapy for Limited Small Brain metastases--a Phase II Trial
NCT07405047CI-TRIAL-00103209completedN/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 is a single-center, open lable, single-arm phase II clinical study to evaluate the efficacy and safety of fractionated stereotactic radiotherapy (FSRT) in patients with 1-4 brain metastases with ≤2cm in diameter.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases, Adult | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fractionated stereotactic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- fractionated stereotactic radiotherapy group
- description
- fractionated stereotactic radiotherapy is given to all the patients. The presciption is 30 Gy in 5 fractions.
- interventionNames
- Radiation: fractionated stereotactic radiotherapy
Primary outcomes (1)
- measure
- local control without symptomatic radiation necrosis rate
- timeFrame
- 1 year after fractionated stereotactic radiotherapy (FSRT)
- description
- radiation necrosis (RN) is defined as: enhanced MRI after radiotherapy shows lace or irregular enhancement around the lesion, less enhancement in the center of T1-WI, high signal around the lesion of T2-WI, and no nodules of equal intensity or low intensity, and no obvious diffusion restriction in DWI sequences. RN can be diagnosed if the above brain MRI findings still exist after 3 months of re-xamination.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The primary tumor is proved malignant by pathology; 2. Brain metastases are confirmed by enhanced MRI, and the number of lesions is 1-4; 3. The maximum diameter of each lesion is ≤ 2cm; 4. Age ≥ 18 years old; 5. KPS≥ 70; 6. Brain metastases haven't been previously treated locally and patients haven't received prior whole brain radiotherapy (WBRT); 7. expected survival of more than 6 months; 8. The functions of vital organs meet the requirements; 9. The patients voluntarily join the clinical study and sign the informed consent. Exclusion Criteria: 1. Surgical intervention is considered for MDT consultation; 2. Meningeal metastasis; 3. The primary tumor is small cell lung cancer; 4. Follow-up data can't be obtained regularly; 5. patients are combined with other serious diseases, such as serious cardiovascular diseases: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc interval ≥ 450 ms in men and ≥ 470 ms in women); Patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) \< 50% indicated by color doppler examination; 6. neurological lesions such as cerebral hemorrhage and cerebral infarction occurred within 6 months; 7. Other circumstances that, in the investigator's judgment, would render the subject unfit for study enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.