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
Recruitment status was Recruiting
Sponsor:
Japan Clinical Oncology Group
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
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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:
- 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
Contacts and Locations
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 Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Central Nervous System Neoplasms Nervous System Neoplasms |
Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013