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

Primary Purpose

Brain Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Whole brain radiation therapy arm
Salvage stereotactic radiosurgery arm
Sponsored by
Haruhiko Fukuda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Neoplasms focused on measuring Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya University School of Medicine
  • Chiba University, Graduate School of Medicine
  • Ehime University Hospital
  • Kyushu University Hospital
  • Hokkaido University Hospital
  • Nakamura Memorial Hospital
  • Iwate Medical University
  • St.Marianna University School of Medicine
  • Kumamoto University Medical School
  • Kyoto University Hospital
  • Tohoku University Hospital
  • Niigata University Medical and Dental Hospital
  • Saitama Medical School Hospital
  • The University of Tokyo Hospital
  • National Cancer Center Hospital
  • Teikyo University School of Medicine
  • Kyorin University School of Medicine
  • Tokyo Women's Medical University
  • Keio University Hospital
  • Yamagata University Faculty of Medicine
  • University of Yamanashi Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Device: Whole brain radiation therapy arm

Device: Salvage stereotactic radiosurgery arm

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

proportion of performance status (PS) preservation
proportion of mini-mental status examination (MMSE) preservation
adverse events

Full Information

First Posted
January 20, 2006
Last Updated
September 20, 2016
Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00280475
Brief Title
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Haruhiko Fukuda
Collaborators
Ministry of Health, Labour and Welfare, Japan

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Neoplasm Metastasis
Keywords
Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Device: Whole brain radiation therapy arm
Arm Title
2
Arm Type
Experimental
Arm Description
Device: Salvage stereotactic radiosurgery arm
Intervention Type
Device
Intervention Name(s)
Whole brain radiation therapy arm
Intervention Description
Whole brain radiation therapy arm
Intervention Type
Device
Intervention Name(s)
Salvage stereotactic radiosurgery arm
Intervention Description
Salvage stereotactic radiosurgery arm
Primary Outcome Measure Information:
Title
overall survival
Time Frame
During the study conduct
Secondary Outcome Measure Information:
Title
proportion of performance status (PS) preservation
Time Frame
During the study conduct
Title
proportion of mini-mental status examination (MMSE) preservation
Time Frame
During the study conduct
Title
adverse events
Time Frame
During the study conduct

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takamasa Kayama, MD, PhD
Organizational Affiliation
Yamagata University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Nagoya University School of Medicine
City
Nagoya,Showa-ku,Tsurumai-cho,65
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Chiba University, Graduate School of Medicine
City
Chiba,Chuo-ku,Inohana,1-8-1
State/Province
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Ehime University Hospital
City
Shitsukawa,Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Facility Name
Kyushu University Hospital
City
Higashi-ku,Maidashi,3-1-1
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Hokkaido University Hospital
City
North-14 West-5 Kita-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Nakamura Memorial Hospital
City
South-1,West-14,Chuou-ku,Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
Iwate Medical University
City
Morioka,Uchimaru,19-1
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
St.Marianna University School of Medicine
City
Kawasaki,Miyamae-ku,Sugao,2-16-1
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kumamoto University Medical School
City
Kumamoto,Honjo,1-1-1
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto,Sakyo-ku,Syogoinkawara,54
State/Province
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai,Aoba-ku,Seiryo-machi,1-1
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata,Asahimachi-dori,1-754
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Saitama Medical School Hospital
City
Iruma-gun,Moroyama-machi,Morohongo,38
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku,Hongo,7-3-1
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
National Cancer Center Hospital
City
Chuo-ku,Tsukiji,5-1-1
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Teikyo University School of Medicine
City
Itabashi-ku,Kaga,2-11-1
State/Province
Tokyo
ZIP/Postal Code
173-8605
Country
Japan
Facility Name
Kyorin University School of Medicine
City
Mitaka,Shinkawa,6-20-2
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Shinjuku-ku,Kawada-cho,8-1
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku,Shinanomachi,35
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Yamagata University Faculty of Medicine
City
Yamagata City,Iida-nishi, 2-2-2
State/Province
Yamagata
ZIP/Postal Code
990-585
Country
Japan
Facility Name
University of Yamanashi Faculty of Medicine
City
Nakakoma,Tamaho,Shimokato,1110
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan

12. IPD Sharing Statement

Links:
URL
http://www.jcog.jp/
Description
Related Info

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

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