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

September 20, 2016 updated by: Haruhiko Fukuda

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: During the study conduct
During the study conduct

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: During the study conduct
During the study conduct
proportion of performance status (PS) preservation
Time Frame: During the study conduct
During the study conduct
proportion of mini-mental status examination (MMSE) preservation
Time Frame: During the study conduct
During the study conduct

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haruhiko Fukuda

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Takamasa Kayama, MD, PhD, Yamagata University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 23, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0504
  • C000000307 (Registry Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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