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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)


Phase 3
20 Years
79 Years
Open (Enrolling)
Both
Brain Neoplasms, Neoplasm Metastasis

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Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

During the study conduct

Safety Issue:

No

Principal Investigator

Takamasa Kayama, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Yamagata University Faculty of Medicine

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG0504

NCT ID:

NCT00280475

Start Date:

January 2006

Completion Date:

January 2013

Related Keywords:

  • Brain Neoplasms
  • Neoplasm Metastasis
  • Randomized Controlled Trials
  • Brain Neoplasms/Secondary
  • Brain Neoplasms/Radiotherapy
  • Radiosurgery
  • Brain Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary

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