Metastatic CancerNCT00003324
Radiation Therapy With or Without Surgery in Treating Patients Who Have Brain Metastases
A study testing conventional surgery and radiation therapy in people with Metastatic Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for 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?
- conventional surgery and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1997to Jul 2006
- Phase
- Interventional
- 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
- Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
- Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
- Refused whole brain radiation therapy OR
- Received prior whole brain radiation therapy and ineligible for other relapse protocols
- 18 and over
- Karnofsky 60-100%
- Life expectancy:At least 3 months
- Concurrent steroids allowed
Who cannot join
- more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
- more than 2 weeks since prior focal radiation
- more than 2 weeks since prior focal surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.
PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.
Read the detailed description
OBJECTIVES:
- Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
- Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
- Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.
OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.
Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.
Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.
Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.
PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.
- Conditions
- Metastatic Cancer
- Being tested
- conventional surgery, radiation therapy
- 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.
conventional surgeryProcedure or surgery
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2003 (estimated)
- Study startDec 1997
- Primary completionJul 2006
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 Metastatic CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith M. Ford, MD, PhD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003324
- Sponsor's protocol ID
- CDR0000066275
- Other IDs
- UCLA-HSPC-9710074, UCLA-HSPC-971007401, NCI-G98-1417
- Status last verified
- Jul 2012
- First submitted
- 1 Nov 1999
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: incidence of intracranial progression and salvage radiotherapy. J Neurooncol. 2003 Jan;61(2):143-9. doi: 10.1023/a:1022173922312.
PubMed 12622453
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors Associated With Successful Omission of Whole Brain Radiotherapy in Patients With 4 or Less Cerebral Metastases Treated With Focal Radiation or Surgery
- ClinicalTrials.gov ID
- NCT00003324
- Acronym / sponsor ID
- CDR0000066275
- Conditions
- Metastatic Cancer
- Keywords
- tumors metastatic to brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 1997
- Primary completion
- Jul 2006 (actual)
- First posted
- 25 Apr 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 in a single high dose. Combining radiation therapy with surgery may be a more effective treatment for brain metastases.
PURPOSE: Clinical trial to study the effectiveness of radiation therapy with or without surgery in treating patients who have brain metastases.
Detailed description
OBJECTIVES:
- Develop prognostic factors for patients with brain metastases treated by focal treatment without concurrent whole brain irradiation.
- Determine whether focal treatment without whole brain radiotherapy produces good long-term outcome in patients with four or less cerebral metastases.
- Assess survival, physical and cognitive functioning, and quality of life of patients treated on this protocol.
OUTLINE: Quality of life is assessed using the FACT-BR scale, physical function is assessed using the FIM scale, and cognition is assessed using two brief pencil and paper tests.
Patients receive focal therapy for cerebral metastases by any combination of (1) surgery plus fractionated stereotactic radiotherapy to surgical bed, or (2) single fraction stereotactic radiotherapy by linear accelerator with or without a radiation sensitizer.
Patients are followed at 2 and 10 weeks, then every 3 months for 18 months, then every 6 months for 3 years, then annually. Quality of life is assessed at each followup visit.
Patients suffering intracerebral relapse are offered further focal therapy if they have no more than 3 metastases, no more than 6 lesions over consecutive scans, and continue to have life expectancy of at least 3 months and Karnofsky performance status of 60-100%. Otherwise, relapsed patients are offered whole brain radiotherapy or supportive treatment with steroids, and may also receive stereotactic boost to the new lesions. Patients who have received prior whole brain irradiation will be offered entry into other protocols if eligible or supportive treatment with steroids. Patients are followed as above.
PROJECTED ACCRUAL: At least 60 patients will be enrolled in this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Biopsy, CT scan, or MRI proven cerebral metastases with known current or previous systemic malignancy OR
- Biopsy proven cerebral metastases other than from small cell lung cancer or lymphoma
- Refused whole brain radiation therapy OR
- Received prior whole brain radiation therapy and ineligible for other relapse protocols
- 18 and over
Key exclusion criteria (3 listed)
- more than four cerebral metastases on MRI scan and suitable for focal treatment with surgery and/or stereotactic radiotherapy with a linear accelerator
- more than 2 weeks since prior focal radiation
- more than 2 weeks since prior focal surgery
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 |
|---|---|---|
| conventional surgery | Procedure or surgery | – |
| radiation therapy | Radiation | – |
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 3 Aug 2020.
- Results publication: PubMed 12622453Chitapanarux I, Goss B, Vongtama R, Frighetto L, De Salles A, Selch M, Duick M, Solberg T, Wallace R, Cabatan-Awang C, Ford J. Prospective study of stereotactic radiosurgery without whole brain radiotherapy in patients with four or less brain metastases: incidence of intracranial progression and salvage radiotherapy. J Neurooncol. 2003 Jan;61(2):143-9. doi: 10.1023/a:1022173922312.
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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.
Judith M. Ford, MD, PhD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional surgery and radiation therapy in people with Metastatic Cancer, run by Jonsson Comprehensive Cancer Center at 1 site 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 8 inclusion and 3 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 3 Aug 2020. 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 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.
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?
On the ClinicalTrials.gov record for NCT00003324, 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 3 Aug 2020.