Clinical trial NCT00280475: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Brain Neoplasms
Neoplasm Metastasis
Keywords: Randomized Controlled Trials
Brain Neoplasms/Secondary
Brain Neoplasms/Radiotherapy
Radiosurgery
Lead sponsor: Japan Clinical Oncology Group
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2006-01-23
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: overall survival
timeFrame: During the study conduct
Secondary outcomes:
measure: proportion of performance status (PS) preservation
timeFrame: During the study conduct
measure: proportion of mini-mental status examination (MMSE) preservation
timeFrame: During the study conduct
measure: adverse events
timeFrame: During the study conduct
Other outcomes:
Locations:
city: Nagoya,Showa-ku,Tsurumai-cho,65
country: Japan
facility: Nagoya University School of Medicine
state: Aichi
city: Chiba,Chuo-ku,Inohana,1-8-1
country: Japan
facility: Chiba University, Graduate School of Medicine
state: Chiba
city: Shitsukawa,Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Higashi-ku,Maidashi,3-1-1
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: North-14 West-5 Kita-ku,Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: South-1,West-14,Chuou-ku,Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Morioka,Uchimaru,19-1
country: Japan
facility: Iwate Medical University
state: Iwate
city: Kawasaki,Miyamae-ku,Sugao,2-16-1
country: Japan
facility: St.Marianna University School of Medicine
state: Kanagawa
city: Kumamoto,Honjo,1-1-1
country: Japan
facility: Kumamoto University Medical School
state: Kumamoto
city: Kyoto,Sakyo-ku,Syogoinkawara,54
country: Japan
facility: Kyoto University Hospital
state: Kyoto
city: Sendai,Aoba-ku,Seiryo-machi,1-1
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Niigata,Asahimachi-dori,1-754
country: Japan
facility: Niigata University Medical and Dental Hospital
state: Niigata
city: Iruma-gun,Moroyama-machi,Morohongo,38
country: Japan
facility: Saitama Medical School Hospital
state: Saitama
city: Bunkyo-ku,Hongo,7-3-1
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chuo-ku,Tsukiji,5-1-1
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Itabashi-ku,Kaga,2-11-1
country: Japan
facility: Teikyo University School of Medicine
state: Tokyo
city: Mitaka,Shinkawa,6-20-2
country: Japan
facility: Kyorin University School of Medicine
state: Tokyo
city: Shinjuku-ku,Kawada-cho,8-1
country: Japan
facility: Tokyo Women's Medical University
state: Tokyo
city: Shinjuku-ku,Shinanomachi,35
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Yamagata City,Iida-nishi, 2-2-2
country: Japan
facility: Yamagata University Faculty of Medicine
state: Yamagata
city: Nakakoma,Tamaho,Shimokato,1110
country: Japan
facility: University of Yamanashi Faculty of Medicine
state: Yamanashi
Study officials:
affiliation: Yamagata University Faculty of Medicine
name: Takamasa Kayama, MD, PhD
role: STUDY_CHAIR
References: