Brain MetastasisNCT00406835
Prospective Randomized Trial Between WBRT Plus SRS Versus SRS Alone for 1-4 Brain Metastases
An observational study of Brain Metastasis, run by Hokkaido University Hospital at 1 site in Japan.
Trial summary
The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis
- What is being tested?
- Whole-Brain Radiation Therapy, Stereotactic Radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteJapan
- Study dates
- Oct 1999to Apr 2005
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more
Who cannot join
- Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases
The purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.
Read the detailed description
Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.
- Conditions
- Brain Metastasis
- Being tested
- Whole-Brain Radiation Therapy, Stereotactic Radiosurgery
- Keywords
- Whole Brain Radiation Therapy, Stereotactic Radiosurgery, Brain metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Brain Radiation Therapy, Stereotactic RadiosurgeryProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startOct 1999
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasisStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Hokkaido University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hidefumi Aoyama, MD, PhD, Principal investigator, Hokkaido University School of MedicineHiroki Shirato, MD, PhD, Study chair, Hokkaido University School of MedicineKeiichi Nakagawa, MD, PhD, Study director, Tokyo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406835
- Sponsor's protocol ID
- JROSG99-1
- Status last verified
- Nov 2006
- First submitted
- 30 Nov 2006
- Last updated
- 4 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Whole Brain Radiation Therapy Plus Stereotactic Radiosurgery Versus Stereotactic Radiosurgery Alone for 1-4 Brain Metastases
- ClinicalTrials.gov ID
- NCT00406835
- Acronym / sponsor ID
- JROSG99-1
- Conditions
- Brain Metastasis
- Keywords
- Whole Brain Radiation Therapy, Stereotactic Radiosurgery, Brain metastases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- Hokkaido University HospitalUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Apr 2005
- First posted
- 4 Dec 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 purpose of this study is to determine if WBRT combined with SRS resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death.
Detailed description
Whole-Brain Radiation Therapy (WBRT) had been a mainstay in the treatment of brain metastases. However, treatment strategy which rely on Stereotactic Radiosurgery (SRS) has becoming popular in Japan. It is not well understood if the Whole-Brain Radiation Therapy (WBRT) combined with Stereotactic Radiosurgery (SRS) resulted in improvements in survival, brain tumor control, functional preservation rate, and frequency of neurologic death. In orer to determine the role of WBRT, we conducted prospective randomized trial between WBRT+SRS and SRS-alone for 1-4 brain metastatic patients.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older with 1-4 brain metastases, each with a maximum diameter of no more than 3 cm on contrast-enhanced MRI scans, and were derived from a histologically confirmed systemic cancer, Karnofsky Performance Status (KPS) score of 70 or more
Key exclusion criteria (1 listed)
- Patients with metastases from small cell carcinoma, lymphoma, germinoma, and multiple myeloma were excluded.
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, Stereotactic Radiosurgery | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 4 Dec 2006.
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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.
Hidefumi Aoyama, MD, PhD principal investigator
Hokkaido University School of Medicine
Hiroki Shirato, MD, PhD study chair
Hokkaido University School of Medicine
Keiichi Nakagawa, MD, PhD study director
Tokyo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastasis, run by Hokkaido University Hospital at 1 site 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 1 inclusion and 1 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 4 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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.
Where can I read the original study information?
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 4 Dec 2006.