Clinical trial · Interventional
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases
Tomotherapy as Primary Radiotherapy for Multipule Brain Metastases:A Single Arm, Single Center,Phase II Trial
NCT04178330CI-TRIAL-00041940completedN/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 as primary radiotherapy for multiple 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 | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group A
- description
- patients with multiple brain metastases (no less than 3 lesions) ,who have not recived whole brain radiotheray (WBRT).
- interventionNames
- Radiation: tomotherapy
Primary outcomes (1)
- measure
- Disease control rate(DCR)
- timeFrame
- 2-3 month after radiation
- description
- Using RTOG9508 criteria, tumor control is defined as CR+PR+SD
Secondary outcomes (5)
- measure
- Overall survival
- timeFrame
- up to 3 years
- description
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;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 organ function:WBC≥4.0x109/L, Neu ≥ 1.5x109/L, Hemoglobin ≥ 110 g/L, Platelets ≥100 x109/L, Totalbilirubin ≤ 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 WBRT. 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.