A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Brain Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Device: Whole brain radiation therapy arm
* Device: Salvage stereotactic radiosurgery arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 all brain metastases localized within cerebrum or cerebellum before surgical resection for brain metastasis, PS is 0-2, or 3 by cerebral nerve compression neurological deficits surgical resection for the largest brain metastases has achieved after surgical resection, four or fewer (0-4) residual lesions with maximum diameter under 3 cm histologically proven non-small cell carcinoma, breast cancer or colorectal cancer primary lesion and the other metastases (i.e. lung, liver, bone metastases except for brain) is consider to be controlled an age of 20-79 years no prior surgery or irradiation for brain adequate organ function 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: synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or mucosal cancer pregnant or breast-feeding women severe mental disease allergic to gadolinium contained contrast agents

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Device: Whole brain radiation therapy arm | Device: Whole brain radiation therapy arm<br>* Whole brain radiation therapy arm<br>|
| Experimental: 2<br>Device: Salvage stereotactic radiosurgery arm | Device: Salvage stereotactic radiosurgery arm<br>* Salvage stereotactic radiosurgery arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | During the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery