Brain NeoplasmsPhase 3NCT00280475
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
A Phase 3 study testing Whole brain radiation therapy arm and Salvage stereotactic radiosurgery arm in people with Brain Neoplasms and Neoplasm Metastasis, run by Haruhiko Fukuda at 21 sites in Japan.
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). Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Brain Neoplasms, Neoplasm Metastasis
- What is being tested?
- Whole brain radiation therapy arm and Salvage stereotactic radiosurgery arm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 21 sitesJapan
- Study dates
- Jan 2006to Jan 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Japan21 sites
The University of Tokyo Hospital
Bunkyo-ku,Hongo,7-3-1, Tokyo, 113-8655
Chiba University, Graduate School of Medicine
Chiba,Chuo-ku,Inohana,1-8-1, Chiba, 260-8670
National Cancer Center Hospital
Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045
Kyushu University Hospital
Higashi-ku,Maidashi,3-1-1, Fukuoka, 812-8582
Saitama Medical School Hospital
Iruma-gun,Moroyama-machi,Morohongo,38, Saitama, 350-0495
Teikyo University School of Medicine
Itabashi-ku,Kaga,2-11-1, Tokyo, 173-8605
St.Marianna University School of Medicine
Kawasaki,Miyamae-ku,Sugao,2-16-1, Kanagawa, 216-8511
Kumamoto University Medical School
Kumamoto,Honjo,1-1-1, Kumamoto, 860-8556
Kyoto University Hospital
Kyoto,Sakyo-ku,Syogoinkawara,54, Kyoto, 606-8507
Kyorin University School of Medicine
Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, 020-8505
Nagoya University School of Medicine
Nagoya,Showa-ku,Tsurumai-cho,65, Aichi-ken, 466-8550
University of Yamanashi Faculty of Medicine
Nakakoma,Tamaho,Shimokato,1110, Yamanashi, 409-3898
Niigata University Medical and Dental Hospital
Niigata,Asahimachi-dori,1-754, Niigata, 951-8520
Hokkaido University Hospital
North-14 West-5 Kita-ku,Sapporo, Hokkaido, 060-8648
Tohoku University Hospital
Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, 980-8574
Tokyo Women's Medical University
Shinjuku-ku,Kawada-cho,8-1, Tokyo, 162-8666
Keio University Hospital
Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582
Ehime University Hospital
Shitsukawa,Toon, Ehime, 791-0295
Nakamura Memorial Hospital
South-1,West-14,Chuou-ku,Sapporo, Hokkaido, 060-8570
Yamagata University Faculty of Medicine
Yamagata City,Iida-nishi, 2-2-2, Yamagata, 990-585
About this study
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)
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).
Read the 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.
- Conditions
- Brain Neoplasms, Neoplasm Metastasis
- Being tested
- Whole brain radiation therapy arm, Salvage stereotactic radiosurgery arm
- Keywords
- Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery
- Medical subject headings
- Brain Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole brain radiation therapy armDevice
Whole brain radiation therapy arm
Salvage stereotactic radiosurgery armDevice
Salvage stereotactic radiosurgery arm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Device: Whole brain radiation therapy arm Receives: Device: Whole brain radiation therapy arm |
| 2 | Experimental | Device: Salvage stereotactic radiosurgery arm Receives: Device: Salvage stereotactic radiosurgery arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: During the study conduct
Secondary outcomes (3)
proportion of performance status (PS) preservation
Measured: During the study conduct
proportion of mini-mental status examination (MMSE) preservation
Measured: During the study conduct
adverse events
Measured: During the study conduct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Takamasa Kayama, MD, PhD, Study chair, Yamagata University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280475
- Sponsor's protocol ID
- JCOG0504
- Other IDs
- C000000307
- Status last verified
- Sep 2016
- First submitted
- 20 Jan 2006
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Simeoli C, Di Paola N, Stigliano A, Lardo P, Kearney T, Mezosi E, Ghigo E, Giordano R, Mariash CN, Donegan DM, Feelders RA, Hand AL, Araque KA, Moraitis AG, Pivonello R. Relacorilant or surgery improved hemostatic markers in Cushing syndrome. J Endocrinol Invest. 2025 Mar;48(3):671-680. doi: 10.1007/s40618-024-02468-2. Epub 2024 Sep 21.
PubMed 39305441
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00280475
- Acronym / sponsor ID
- JCOG0504
- Conditions
- Brain Neoplasms, Neoplasm Metastasis
- Keywords
- Randomized Controlled Trials, Brain Neoplasms/Secondary, Brain Neoplasms/Radiotherapy, Radiosurgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jan 2006
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Whole brain radiation therapy armDevice: Whole brain radiation therapy arm |
| 2 | Experimental | Device: Salvage stereotactic radiosurgery armDevice: Salvage stereotactic radiosurgery arm |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole brain radiation therapy armWhole brain radiation therapy arm | Device | 1 |
| Salvage stereotactic radiosurgery armSalvage stereotactic radiosurgery arm | Device | 2 |
Primary outcome
overall survival
Time frame: During the study conduct
3 secondary outcomes
proportion of performance status (PS) preservation
Time frame: During the study conduct
proportion of mini-mental status examination (MMSE) preservation
Time frame: During the study conduct
adverse events
Time frame: During the study conduct
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 39305441Simeoli C, Di Paola N, Stigliano A, Lardo P, Kearney T, Mezosi E, Ghigo E, Giordano R, Mariash CN, Donegan DM, Feelders RA, Hand AL, Araque KA, Moraitis AG, Pivonello R. Relacorilant or surgery improved hemostatic markers in Cushing syndrome. J Endocrinol Invest. 2025 Mar;48(3):671-680. doi: 10.1007/s40618-024-02468-2. Epub 2024 Sep 21.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takamasa Kayama, MD, PhD study chair
Yamagata University Faculty of Medicine
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Whole brain radiation therapy arm and Salvage stereotactic radiosurgery arm in people with Brain Neoplasms and Neoplasm Metastasis, run by Haruhiko Fukuda at 21 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: During the study conduct). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00280475, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.