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

Neoplasm Metastasis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280475
• Other study ID #: JCOG0504
• Secondary ID: C000000307
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2006
• Last updated: September 20, 2016
• Start date: January 2006
• Est. completion date: January 2013

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Device:
• Whole brain radiation therapy arm
Whole brain radiation therapy arm
• Salvage stereotactic radiosurgery arm
Salvage stereotactic radiosurgery arm

Locations

Country	Name	City	State
Japan	The University of Tokyo Hospital	Bunkyo-ku,Hongo,7-3-1	Tokyo
Japan	Chiba University, Graduate School of Medicine	Chiba,Chuo-ku,Inohana,1-8-1	Chiba
Japan	National Cancer Center Hospital	Chuo-ku,Tsukiji,5-1-1	Tokyo
Japan	Kyushu University Hospital	Higashi-ku,Maidashi,3-1-1	Fukuoka
Japan	Saitama Medical School Hospital	Iruma-gun,Moroyama-machi,Morohongo,38	Saitama
Japan	Teikyo University School of Medicine	Itabashi-ku,Kaga,2-11-1	Tokyo
Japan	St.Marianna University School of Medicine	Kawasaki,Miyamae-ku,Sugao,2-16-1	Kanagawa
Japan	Kumamoto University Medical School	Kumamoto,Honjo,1-1-1	Kumamoto
Japan	Kyoto University Hospital	Kyoto,Sakyo-ku,Syogoinkawara,54	Kyoto
Japan	Kyorin University School of Medicine	Mitaka,Shinkawa,6-20-2	Tokyo
Japan	Iwate Medical University	Morioka,Uchimaru,19-1	Iwate
Japan	Nagoya University School of Medicine	Nagoya,Showa-ku,Tsurumai-cho,65	Aichi
Japan	University of Yamanashi Faculty of Medicine	Nakakoma,Tamaho,Shimokato,1110	Yamanashi
Japan	Niigata University Medical and Dental Hospital	Niigata,Asahimachi-dori,1-754	Niigata
Japan	Hokkaido University Hospital	North-14 West-5 Kita-ku,Sapporo	Hokkaido
Japan	Tohoku University Hospital	Sendai,Aoba-ku,Seiryo-machi,1-1	Miyagi
Japan	Tokyo Women's Medical University	Shinjuku-ku,Kawada-cho,8-1	Tokyo
Japan	Keio University Hospital	Shinjuku-ku,Shinanomachi,35	Tokyo
Japan	Ehime University Hospital	Shitsukawa,Toon	Ehime
Japan	Nakamura Memorial Hospital	South-1,West-14,Chuou-ku,Sapporo	Hokkaido
Japan	Yamagata University Faculty of Medicine	Yamagata City,Iida-nishi, 2-2-2	Yamagata

Sponsors (2)

Lead Sponsor	Collaborator
Haruhiko Fukuda	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		During the study conduct	No
Secondary	proportion of performance status (PS) preservation		During the study conduct	Yes
Secondary	proportion of mini-mental status examination (MMSE) preservation		During the study conduct	Yes
Secondary	adverse events		During the study conduct	Yes

External Links

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