Clinical trial · Interventional
Tomotherapy for Refractory Brain Metastases
Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
NCT03027544CI-TRIAL-00025579TRBMunknownN/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 clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.
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 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases. Intervention：tomotherapy
- interventionNames
- Radiation: tomotherapy
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 2-3 months after radiation
- description
- Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
Secondary outcomes (6)
- measure
- Overall survival rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytologic diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate end-organ function: WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range. Exclusion Criteria: * • Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia). * Unable or unwilling to comply with the study protocol. * The expected survival time is less than 3 months. * Patients who are anticipated in other clinical trials of brain metastases. * Patients who has been treated with SRT in other hospitals * Pregnant patients or female patients whose HCG is positive * Unsuitable to participate in study, that in the opinion of the treating physician.
References
Publications (0)
Data not yet available
No reference posted for this study.