Metastatic CancerPhase 2NCT00006456
Stereotactic Radiosurgery in Treating Patients With Liver Metastases, Lung Metastases, or Other Advanced Solid Tumors
A Phase 2 study testing stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Nov 2004
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed malignancy
- Extracranial recurrent or metastatic disease or primary tumor not predicted to be controlled with standard radiotherapy
- Incurable with any standard therapy
- No tumors involving critical structures (e.g., mucosal surfaces (bowel or bladder) or heart)
- Tumor visible by CT scan
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 2.0 times upper limit of normal (ULN)
- AST and ALT less than 5 times ULN
Renal:
- Creatinine less than 2.0 mg/dL
Pulmonary:
- FEV1 greater than 0.75 L
Other:
- No unsuitable size or geometric proportion that would preclude stereotactic immobilization
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 14 days since prior anticancer biologic therapy and recovered
Chemotherapy:
- At least 14 days since prior anticancer chemotherapy and recovered
Endocrine therapy:
- At least 14 days since prior anticancer endocrine therapy and recovered
Radiotherapy:
- See Disease Characteristics
- At least 14 days since prior anticancer radiotherapy and recovered
Surgery:
- Not specified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors
RATIONALE: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.
- Assess the toxicities of this treatment regimen in these patients.
- Determine tumor response and cause of death in these patients treated with this regimen.
OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.
- Being tested
- stereotactic radiosurgery
- Keywords
- unspecified adult solid tumor, protocol specific, lung metastases, liver metastases
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiosurgeryRadiation
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 startFeb 1999
- Primary completionNov 2004
- Study completionNov 2004
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 Virginia Commonwealth UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Danny Y. Song, MD, Study chair, Massey Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006456
- Sponsor's protocol ID
- CDR0000068151
- Other IDs
- P30CA016059, MCV-MCC-9812-2C, NCI-V00-1612
- Status last verified
- Feb 2010
- First submitted
- 6 Nov 2000
- Last updated
- 24 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractionated Stereotactic Body Radiosurgery for Extracranial Tumors
- ClinicalTrials.gov ID
- NCT00006456
- Acronym / sponsor ID
- CDR0000068151
- Keywords
- unspecified adult solid tumor, protocol specific, lung metastases, liver metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1999
- Primary completion
- Nov 2004 (actual)
- Study completion
- Nov 2004 (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: Stereotactic radiosurgery delivers x-rays directly to the tumor and may cause less damage to normal tissue.
PURPOSE: Phase II trial to study the effectiveness of stereotactic radiosurgery in treating patients who have liver metastases, lung metastases, or other advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the feasibility of fractionated stereotactic body radiosurgery in patients with advanced extracranial tumors.
- Assess the toxicities of this treatment regimen in these patients.
- Determine tumor response and cause of death in these patients treated with this regimen.
OUTLINE: Patients receive fractionated stereotactic body radiosurgery over 30 minutes for 5-10 days for a total of 3 treatments.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 10-25 patients will be accrued within 2-3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| stereotactic radiosurgery | 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 24 Feb 2010.
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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.
Danny Y. Song, MD study chair
Massey Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2010. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 24 Feb 2010.