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

Last updated: September 20, 2016
Sponsor: Haruhiko Fukuda
Overall Status: Completed

Phase

3

Condition

Neoplasm Metastasis

Neoplasms

Treatment

N/A

Clinical Study ID

NCT00280475
JCOG0504
C000000307
  • Ages 20-79
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. one to four brain metastases with a maximum diameter of 3 cm or more for the largestlesion 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 nervecompression 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 diameterunder 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 forbrain) 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 dueto paralysis, signing by the family in place of the patient is permitted)

Exclusion

Exclusion Criteria:

  1. synchronous or metachronous (within 5 years) malignancy other than carcinoma in situor mucosal cancer

  2. pregnant or breast-feeding women

  3. severe mental disease

  4. allergic to gadolinium contained contrast agents

Study Design

Total Participants: 270
Study Start date:
January 01, 2006
Estimated Completion Date:
January 31, 2013

Study 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.

Connect with a study center

  • Nagoya University School of Medicine

    65 Tsurumai-cho,Showa-ku,Nagoya, Aichi 466-8550
    Japan

    Site Not Available

  • Nagoya University School of Medicine

    Nagoya,Showa-ku,Tsurumai-cho,65, Aichi 466-8550
    Japan

    Site Not Available

  • Chiba University, Graduate School of Medicine

    1-8-1,Inohana,Chuo-ku,Chiba, Chiba 260-8670
    Japan

    Site Not Available

  • Chiba University, Graduate School of Medicine

    Chiba,Chuo-ku,Inohana,1-8-1, Chiba 260-8670
    Japan

    Site Not Available

  • Ehime University Hospital

    Shitsukawa,Toon, Ehime 791-0295
    Japan

    Site Not Available

  • Kyushu University Hospital

    3-1-1,Maidashi,Higashi-ku, Fukuoka 812-8582
    Japan

    Site Not Available

  • Kyushu University Hospital

    Higashi-ku,Maidashi,3-1-1, Fukuoka 812-8582
    Japan

    Site Not Available

  • Hokkaido University Hospital

    North-14 West-5 Kita-ku,Sapporo, Hokkaido 060-8648
    Japan

    Site Not Available

  • Nakamura Memorial Hospital

    South-1,West-14,Chuou-ku,Sapporo, Hokkaido 060-8570
    Japan

    Site Not Available

  • Iwate Medical University

    19-1,Uchimaru,Morioka, Iwate 020-8505
    Japan

    Site Not Available

  • Iwate Medical University

    Morioka,Uchimaru,19-1, Iwate 020-8505
    Japan

    Site Not Available

  • St.Marianna University School of Medicine

    2-16-1,Sugao,Miyamae-ku,Kawasaki, Kanagawa 216-8511
    Japan

    Site Not Available

  • St.Marianna University School of Medicine

    Kawasaki,Miyamae-ku,Sugao,2-16-1, Kanagawa 216-8511
    Japan

    Site Not Available

  • Kumamoto University Medical School

    1-1-1,Honjo,Kumamoto, Kumamoto 860-8556
    Japan

    Site Not Available

  • Kumamoto University Medical School

    Kumamoto,Honjo,1-1-1, Kumamoto 860-8556
    Japan

    Site Not Available

  • Kyoto University Hospital

    54,Syogoinkawara,Sakyo-ku,Kyoto, Kyoto 606-8507
    Japan

    Site Not Available

  • Kyoto University Hospital

    Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto 606-8507
    Japan

    Site Not Available

  • Tohoku University Hospital

    1-1,Seiryo-machi,Aoba-ku,Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi 980-8574
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    1-754,Asahimachi-dori,Niigata, Niigata 951-8520
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigata,Asahimachi-dori,1-754, Niigata 951-8520
    Japan

    Site Not Available

  • Saitama Medical School Hospital

    38,Morohongo,Moroyama-machi,Iruma-gun, Saitama 350-0495
    Japan

    Site Not Available

  • Saitama Medical School Hospital

    Iruma-gun,Moroyama-machi,Morohongo,38, Saitama 350-0495
    Japan

    Site Not Available

  • Teikyo University School of Medicine

    2-11-1,Kaga,Itabashi-ku, Tokyo 173-8605
    Japan

    Site Not Available

  • Keio University Hospital

    35,Shinanomachi,Shinjuku-ku, Tokyo 160-8582
    Japan

    Site Not Available

  • National Cancer Center Hospital

    5-1-1,Tsukiji,Chuo-ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kyorin University School of Medicine

    6-20-2,Shinkawa,Mitaka, Tokyo 181-8611
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    7-3-1,Hongo,Bunkyo-ku, Tokyo 113-8655
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    8-1,Kawada-cho,Shinjuku-ku, Tokyo 162-8666
    Japan

    Site Not Available

  • The University of Tokyo Hospital

    Bunkyo-ku,Hongo,7-3-1, Tokyo 113-8655
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku,Tsukiji,5-1-1, Tokyo 104-0045
    Japan

    Site Not Available

  • Teikyo University School of Medicine

    Itabashi-ku,Kaga,2-11-1, Tokyo 173-8605
    Japan

    Site Not Available

  • Kyorin University School of Medicine

    Mitaka,Shinkawa,6-20-2, Tokyo 181-8611
    Japan

    Site Not Available

  • Tokyo Women's Medical University

    Shinjuku-ku,Kawada-cho,8-1, Tokyo 162-8666
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjuku-ku,Shinanomachi,35, Tokyo 160-8582
    Japan

    Site Not Available

  • Yamagata University Faculty of Medicine

    2-2-2 Iida-nishi, Yamagata City, Yamagata 990-585
    Japan

    Site Not Available

  • Yamagata University Faculty of Medicine

    Yamagata City,Iida-nishi, 2-2-2, Yamagata 990-585
    Japan

    Site Not Available

  • University of Yamanashi Faculty of Medicine

    1110,Shimokato,Tamaho,Nakakoma, Yamanashi 409-3898
    Japan

    Site Not Available

  • University of Yamanashi Faculty of Medicine

    Nakakoma,Tamaho,Shimokato,1110, Yamanashi 409-3898
    Japan

    Site Not Available

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