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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Japan Clinical Oncology Group.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00280475
First received: January 20, 2006
Last updated: June 13, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Brain Neoplasms
Neoplasm Metastasis
Device: Whole brain radiation therapy arm
Device: Salvage stereotactic radiosurgery arm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of performance status (PS) preservation [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • proportion of mini-mental status examination (MMSE) preservation [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: During the study conduct ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 270
Study Start Date: January 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280475

Contacts
Contact: Shinya Sato, MD, PhD 81-23-628-5349 JCOG_sir@ml.jcog.jp
Contact: Kaori Sakurada, MD, PhD 81-23-628-5349 JCOG_sir@ml.jcog.jp

Locations
Japan
Nagoya University School of Medicine Recruiting
65 Tsurumai-cho,Showa-ku,Nagoya, Aichi, Japan, 466-8550
Contact: Toshihiko Wakabayashi, M.D., Ph.D.    81-52-744-2355      
Chiba University, Graduate School of Medicine Recruiting
1-8-1,Inohana,Chuo-ku,Chiba, Chiba, Japan, 260-8670
Contact: Yasuo Iwadate, M.D.    81-43-226-2158      
Ehime University Hospital Recruiting
Shitsukawa,Toon, Ehime, Japan, 791-0295
Contact: Hironobu Harada, M.D.    81-89-960-5338      
Kyushu University Hospital Recruiting
3-1-1,Maidashi,Higashi-ku, Fukuoka, Japan, 812-8582
Contact: Tadahisa Shono, M.D., Ph.D.    81-92-642-5524      
Hokkaido University Hospital Recruiting
North-14 West-5 Kita-ku,Sapporo, Hokkaido, Japan, 060-8648
Contact: Yutaka Sawamura, M.D., Ph.D    81-11-706-5987      
Nakamura Memorial Hospital Recruiting
South-1,West-14,Chuou-ku,Sapporo, Hokkaido, Japan, 060-8570
Contact: Tamio Ito, M.D.    81-11-231-8555      
Iwate Medical University Recruiting
19-1,Uchimaru,Morioka, Iwate, Japan, 020-8505
Contact: Takaaki Beppu, M.D.    81-19-651-5111      
St.Marianna University School of Medicine Recruiting
2-16-1,Sugao,Miyamae-ku,Kawasaki, Kanagawa, Japan, 216-8511
Contact: Katsuyuki Tanaka, M.D.    81-44-977-8111      
Kumamoto University Medical School Recruiting
1-1-1,Honjo,Kumamoto, Kumamoto, Japan, 860-8556
Contact: Hideo Nakamura, M.D., Ph.D.    81-96-373-5219      
Kyoto University Hospital Recruiting
54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto, Japan, 606-8507
Contact: Jun Takahashi, M.D., Ph.D.    81-75-751-3459      
Tohoku University Hospital Recruiting
1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi, Japan, 980-8574
Contact: Toshihiro Kumabe, M.D.    81-22-717-7230      
Niigata University Medical and Dental Hospital Recruiting
1-754,Asahimachi-dori,Niigata, Niigata, Japan, 951-8520
Contact: Hideaki Takahashi, M.D.    81-25-227-0652      
Saitama Medical School Hospital Recruiting
38,Morohongo,Moroyama-machi,Iruma-gun, Saitama, Japan, 350-0495
Contact: Kazuhiko Mishima, M.D.    81-49-276-1334      
Teikyo University School of Medicine Recruiting
2-11-1,Kaga,Itabashi-ku, Tokyo, Japan, 173-8605
Contact: Takamitsu Fujimaki, M.D.    81-3-3964-2415      
Keio University Hospital Recruiting
35,Shinanomachi,Shinjuku-ku, Tokyo, Japan, 160-8582
Contact: Takahito Yazaki, M.D., Ph.D.    81-3-5363-3808      
National Cancer Center Hospital Recruiting
5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045
Contact: Soichiro Shibui, M.D., Ph.D.    81-3-3542-2511      
Kyorin University School of Medicine Recruiting
6-20-2,Shinkawa,Mitaka, Tokyo, Japan, 181-8611
Contact: Motoo Nagane, M.D., Ph.D    81-422-47-5511      
The University of Tokyo Hospital Recruiting
7-3-1,Hongo,Bunkyo-ku, Tokyo, Japan, 113-8655
Contact: Minoru Tanaka, M.D., Ph.D    81-3-5800-8853      
Tokyo Women's Medical University Recruiting
8-1,Kawada-cho,Shinjuku-ku, Tokyo, Japan, 162-8666
Contact: Yoshihiro Muragaki, M.D.    81-3-3353-8111      
Yamagata University Faculty of Medicine Recruiting
2-2-2 Iida-nishi, Yamagata City, Yamagata, Japan, 990-585
Contact: Kaori Sakurada, MD, PhD    81-23-628-5349      
University of Yamanashi Faculty of Medicine Recruiting
1110,Shimokato,Tamaho,Nakakoma, Yamanashi, Japan, 409-3898
Contact: Eiji Satoh, M.D.    81-55-273-6786      
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Takamasa Kayama, MD, PhD Yamagata University Faculty of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Takamasa Kayama, MD, PhD, Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00280475     History of Changes
Other Study ID Numbers: JCOG0504, C000000307
Study First Received: January 20, 2006
Last Updated: June 13, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on October 30, 2014