Clinical trial · Interventional
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
Randomized Phase III Trial of Postoperative Whole Brain Radiation Therapy Compared With Salvage Stereotactic Radiosurgery in Patients With One to Four Brain Metastasis: Japan Clinical Oncology Group Study (JCOG 0504)
NCT00280475CI-TRIAL-00023999completedPhase 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)
The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery (SRS) in the patients who received surgical resection for brain metastases in comparison with postoperative whole brain radiation therapy (WBRT).
Conditions
Conditions (2)
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 Neoplasms | Brain Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Salvage stereotactic radiosurgery arm | Device | — | UNRESOLVED |
| Whole brain radiation therapy arm | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Device: Whole brain radiation therapy arm
- interventionNames
- Device: Whole brain radiation therapy arm
- type
- EXPERIMENTAL
- label
- 2
- description
- Device: Salvage stereotactic radiosurgery arm
- interventionNames
- Device: Salvage stereotactic radiosurgery arm
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- During the study conduct
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: 1. one to four brain metastases with a maximum diameter of 3 cm or more for the largest lesion and additional lesions not exceeding 3 cm in diameter 2. all brain metastases localized within cerebrum or cerebellum 3. before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits 4. surgical resection for the largest brain metastases has achieved 5. after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm 6. histologically proven non-small cell carcinoma, breast cancer or colorectal cancer 7. primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled 8. an age of 20-79 years 9. no prior surgery or irradiation for brain 10. adequate organ function 11. written informed consent(If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient is permitted) Exclusion Criteria: 1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer 2. pregnant or breast-feeding women 3. severe mental disease 4. allergic to gadolinium contained contrast agents
References
Publications (1)
- DERIVEDSimeoli C, Di Paola N, Stigliano A, Lardo P, Kearney T, Mezosi E, Ghigo E, Giordano R, Mariash CN, Donegan DM, Feelders RA, Hand AL, Araque KA, Moraitis AG, Pivonello R. Relacorilant or surgery improved hemostatic markers in Cushing syndrome. J Endocrinol Invest. 2025 Mar;48(3):671-680. doi: 10.1007/s40618-024-02468-2. Epub 2024 Sep 21. PMID 39305441