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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00280475

Enrollment

270

Registered

2006-01-23

Start date

2006-01-31

Completion date

2013-01-31

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms, Neoplasm Metastasis

Keywords

Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery

Brief summary

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).

Detailed description

A randomized phase III study is started in Japan to compare postoperative whole brain radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain metastases from lung, breast, and colorectal cancer. Total of 270 patients will be accrued for this study from 21 institutions within three years. The primary endpoint is overall survival. The secondary endpoints are proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.

Interventions

DEVICEWhole brain radiation therapy arm

Whole brain radiation therapy arm

DEVICESalvage stereotactic radiosurgery arm

Salvage stereotactic radiosurgery arm

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
overall survival	During the study conduct

Secondary

Measure	Time frame
proportion of performance status (PS) preservation	During the study conduct
proportion of mini-mental status examination (MMSE) preservation	During the study conduct
adverse events	During the study conduct

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026