Clinical trial · Interventional
HFSRT With Concurrent TMZ for Large BMs
Hypofractionated Radiotherapy With Concurrent Temozolomide for Large Brain Metastases: a Multi-center Randomized Phase III Trial
NCT03778541CI-TRIAL-00039639unknownPhase 3ClinicalTrials.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)
A multi-center randomized phase III trial was conducted to investigate the feasibility and safety of adding temozolomide to hypofractionated stereotactic radiotherapy for large brain metastases.
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 |
|---|---|---|---|
| Brain Metastases | Brain Neoplasm | PROBABILISTIC | 0.70 |
| Chemotherapy | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CRT group
- description
- patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy plus concomitant Temozolomide.
- interventionNames
- Drug: Temozolomide
- Radiation: hypofractionated radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- RT group
- description
- patients with brain metastases of more than 6 cc and treated with fractionated stereotactic radiotherapy alone.
- interventionNames
- Radiation: hypofractionated radiotherapy
Primary outcomes (1)
- measure
- intracranial progression free survival (IPFS) rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histologic or cytological diagnosis of primary tumor and conformed brain metastases by enhanced MRI or CT; * the number of BMs ≤ 3 * the tumor volume ≥6cc, or maximum diameter of BMs≥ 3cm; * Karnofsky performance score (KPS)≥60, or KPS≥40 but simply caused by BMs; * Age: 18-75 years old; * Adequate function of major organs, and blood test reached the following level: WBC≥4.0x109/L, NEU≥1.5x109/L Hemoglobin≥110 g/L, Platelets≥100 x109/L; Liver function test results\<1.5 times the institutional upper limit of normal (ULN); BUN and Cr: within the normal range. Exclusion Criteria: * patient with other clinically significant diseases (e.g. myocardial infarction within the past 6 months, severe arrhythmia); * unable or unwilling to comply with the study protocol; * patient whose survival expectancy was less than 3 months; * the large BM locates in brainstem; * patient who anticipated in other clinical trials of brain metastases; * the large lesions have been treated with SRT in other hospitals; * pregnant patients or female patients whose HCG is positive.
References
Publications (0)
Data not yet available
No reference posted for this study.