We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00280475
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : September 22, 2016
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Brain Neoplasms Neoplasm Metastasis Device: Whole brain radiation therapy arm Device: Salvage stereotactic radiosurgery arm Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2006
Primary Completion Date : January 2013
Study Completion Date : January 2013
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Device: Whole brain radiation therapy arm
Device: Whole brain radiation therapy arm
Whole brain radiation therapy arm
Experimental: 2
Device: Salvage stereotactic radiosurgery arm
Device: Salvage stereotactic radiosurgery arm
Salvage stereotactic radiosurgery arm

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: During the study conduct ]

Secondary Outcome Measures :
  1. proportion of performance status (PS) preservation [ Time Frame: During the study conduct ]
  2. proportion of mini-mental status examination (MMSE) preservation [ Time Frame: During the study conduct ]
  3. adverse events [ Time Frame: During the study conduct ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280475

Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi, Japan, 466-8550
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, Japan, 260-8670
Ehime University Hospital
Shitsukawa,Toon, Ehime, Japan, 791-0295
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, Japan, 812-8582
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Nakamura Memorial Hospital
South-1,West-14,Chuou-ku,Sapporo, Hokkaido, Japan, 060-8570
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, Japan, 020-8505
St.Marianna University School of Medicine
Kawasaki,Miyamae-ku,Sugao,2-16-1, Kanagawa, Japan, 216-8511
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, Japan, 860-8556
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, Japan, 606-8507
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, Japan, 951-8520
Saitama Medical School Hospital
Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, Japan, 350-0495
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, Japan, 113-8655
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, Japan, 104-0045
Teikyo University School of Medicine
Itabashi-ku,Kaga,2-11-1, Tokyo, Japan, 173-8605
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, Japan, 162-8666
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, Japan, 160-8582
Yamagata University Faculty of Medicine
Yamagata City,Iida-nishi, 2-2-2, Yamagata, Japan, 990-585
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, Japan, 409-3898
Sponsors and Collaborators
Haruhiko Fukuda
Ministry of Health, Labour and Welfare, Japan
Study Chair: Takamasa Kayama, MD, PhD Yamagata University Faculty of Medicine
More Information

Additional Information:
Responsible Party: Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00280475     History of Changes
Other Study ID Numbers: JCOG0504
C000000307 ( Registry Identifier: UMIN-CTR )
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by Haruhiko Fukuda, Japan Clinical Oncology Group:
Randomized Controlled Trials
Brain Neoplasms/Secondary
Brain Neoplasms/Radiotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases