Clinical trial · Interventional
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have 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 |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiation therapy | Radiation | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
| WBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- radiosurgery
- description
- Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
- interventionNames
- Radiation: radiation therapy
- Procedure: surgery
- type
- EXPERIMENTAL
- label
- radiosurgery + WBRT
- description
- Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
- interventionNames
- Radiation: radiation therapy
- Procedure: surgery
- Radiation: WBRT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of cerebral metastases meeting all of the following requirements: * 1-3 de novo lesions * Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s) * Each lesion must be less than 3.0 cm by contrasted MRI of the brain * Lesions must not be within 5 mm of optic chiasm or within the brainstem * No primary germ cell tumor, small cell carcinoma, or lymphoma * No leptomeningeal metastases * Eligible for treatment with gamma knife or linear accelerator-based radiosurgery * Performance status - ECOG 0-2 * Performance status - Zubrod 0-2 * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception \* Male patients must continue to use contraception for 3 months after the completion of radiotherapy * No pacemaker or other MRI-incompatible metal in body * No known allergy to gadolinium * Deemed to be at low risk for recurrence from any prior malignancies * At least 7 days since prior chemotherapy * Concurrent hormonal agents allowed * Concurrent steroids allowed * No prior cranial radiotherapy * No prior resection of cerebral metastasis * Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
References
Publications (0)
Data not yet available