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)

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 III trial of postoperative WBRT vs. salvage SRT for one to four brain metastasis. JCOG0504

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000307

Enrollment

270

Registered

2006-01-18

Start date

2006-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain neoplasms/secondary

Interventions

A: Whole brain radiation therapy arm Patients receive WBRT in daily 2.5Gy fractions to a total 37.5 Gy over 3 weeks. No concomitant systemic therapy is given in WBRT period.

Eligibility

Sex/Gender

All

Inclusion 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 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, colorectal cancer, renal carcinoma, ovarian cancer, cervical cancer, endometrial cancer, gastric cancer or esophageal 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

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

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
proportion of performance status (PS) preservation, proportion of mini-mental status examination (MMSE) preservation, and adverse events.	—

Countries

Japan

Contacts

Public ContactShinya Sato, MD, PhD

JCOG0504 Coordinating Office Department of Neurosurgery, Yamagata University Faculty of Medicine

JCOG_sir@ml.jcog.jp023-628-5349

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026