Metastatic CancerPhase 3NCT00030628
Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase 3 study testing radiation therapy, surgery and WBRT in people with Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 37 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- radiation therapy, surgery and WBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 37 sitesUnited States
- Study dates
- Dec 2001to Oct 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cerebral metastases meeting all of the following requirements:
- 1-3 de novo lesions
- Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
- Each lesion must be less than 3.0 cm by contrasted MRI of the brain
- Lesions must not be within 5 mm of optic chiasm or within the brainstem
- No primary germ cell tumor, small cell carcinoma, or lymphoma
Show all 23Show fewer
- No leptomeningeal metastases
- Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Male patients must continue to use contraception for 3 months after the completion of radiotherapy
- No pacemaker or other MRI-incompatible metal in body
- No known allergy to gadolinium
- Deemed to be at low risk for recurrence from any prior malignancies
- At least 7 days since prior chemotherapy
- Concurrent hormonal agents allowed
- Concurrent steroids allowed
- No prior cranial radiotherapy
- No prior resection of cerebral metastasis
- Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Who cannot join
None listed.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
American Fork Hospital
American Fork, Utah, 84003
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3295
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 28232-2861
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
University of Illinois Medical Center
Chicago, Illinois, 60612
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Mount Diablo Regional Cancer Center
Concord, California, 94524-4110
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, 52803
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, 48202
American College of Surgeons Oncology Group
Durham, North Carolina, 27705
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
John F. Kennedy Medical Center
Edison, New Jersey, 08818
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, 32610-100277
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-7375
Methodist Cancer Center at Methodist University Hospital
Memphis, Tennessee, 38104
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8040
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85001-2071
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
University of Pittsburgh Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, 15213-2582
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, 23298-0631
Sutter Cancer Center
Sacramento, California, 95816
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, 63110
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210
John Muir Comprehensive Cancer Center at John Muir Medical Center
Walnut Creek, California, 94598
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082
About this study
Official title: A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Read the detailed description
OBJECTIVES:
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
- Compare the time to CNS failure (brain) in patients treated with these regimens.
- Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
- Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiosurgery.
- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
- Conditions
- Metastatic Cancer
- Being tested
- radiation therapy, surgery, WBRT
- Keywords
- tumors metastatic to brain
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
surgeryProcedure or surgery
WBRTRadiation
| Study group | Role | What they receive |
|---|---|---|
| radiosurgery | Experimental | Patients undergo radiosurgery.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Receives: Radiation: radiation therapy; Procedure: surgery |
| radiosurgery + WBRT | Experimental | Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. Receives: Radiation: radiation therapy; Procedure: surgery; Radiation: WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Measured: Up to 6 months
Secondary outcomes (3)
Time to CNS failure
Measured: Up to 4 years
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Measured: From baseline to up to 3 months
Change in the duration of functional independence using the Barthel ADL Index score
Measured: From baseline to up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startDec 2001
- Primary completionMar 2005
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe sponsor's other registered studies.
- 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
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anthony Asher, MD, FACS, Study chair, Carolina Neurosurgery and Spine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030628
- Sponsor's protocol ID
- ACOSOG-Z0300
- Other IDs
- ACOSOG-Z0300, CDR0000069183
- Status last verified
- Jul 2016
- First submitted
- 14 Feb 2002
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
- ClinicalTrials.gov ID
- NCT00030628
- Acronym / sponsor ID
- ACOSOG-Z0300
- Conditions
- Metastatic Cancer
- Keywords
- tumors metastatic to brain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2001
- Primary completion
- Mar 2005 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Detailed description
OBJECTIVES:
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
- Compare the time to CNS failure (brain) in patients treated with these regimens.
- Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
- Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiosurgery.
- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiosurgery | Experimental | Radiation: radiation therapy, Procedure: surgeryPatients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. |
| radiosurgery + WBRT | Experimental | Radiation: radiation therapy, Procedure: surgery, Radiation: WBRTPatients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Diagnosis of cerebral metastases meeting all of the following requirements:
- No primary germ cell tumor, small cell carcinoma, or lymphoma
- No leptomeningeal metastases
- Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
- Performance status - ECOG 0-2
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| radiation therapy | Radiation | radiosurgery, radiosurgery + WBRT |
| surgery | Procedure or surgery | radiosurgery, radiosurgery + WBRT |
| WBRT | Radiation | radiosurgery + WBRT |
Primary outcome
Overall survival (OS)
Time frame: Up to 6 months
3 secondary outcomes
Time to CNS failure
Time frame: Up to 4 years
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Time frame: From baseline to up to 3 months
Change in the duration of functional independence using the Barthel ADL Index score
Time frame: From baseline to up to 4 years
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 7 Jul 2016.
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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.
Anthony Asher, MD, FACS study chair
Carolina Neurosurgery and Spine Associates
37 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 radiation therapy, surgery and WBRT in people with Metastatic Cancer, run by Alliance for Clinical Trials in Oncology at 37 sites in United States.
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 23 inclusion and 0 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. 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 (OS) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
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 7 Jul 2016.