Neoplasms, MetastaticNCT00178399
A Study For Using Radiosurgery On Limited Metastases
A study testing Stereotactic Body Radiation Therapy in people with Neoplasms, Metastatic, run by University of Rochester at 1 site in United States.
Trial summary
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Metastatic
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to 15 Mar 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- KPS ≥ 70
- Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
- The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol
- Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
- Informed consent must be obtained.
- Pregnancy test must be negative for women of child bearing potential.
- Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.
Who cannot join
- Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
- Women who are pregnant or nursing..
- Failure to meet inclusion requirements
- Contraindications to radiation.
- Patient should not be eligible for primary disease specific radiosurgical protocols
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Department of Radiation Oncology
Rochester, New York, 14642
About this study
Official title: A Pilot Study For Using Radiosurgery On Limited Metastases
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
Read the detailed description
In this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
- Conditions
- Neoplasms, Metastatic
- Being tested
- Stereotactic Body Radiation Therapy
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Not described Receives: Procedure: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Curatively Treated Patients With Progression-free Survival
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Measured: 24 months
Percentage of Palliatively Treated Patients With Progression-free Survival
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
Measured: 24 months
Secondary outcomes (2)
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
Correlation of data from QOL questionnaires and blood markers.
Measured: 30 months from date of registration.
Analyze Impact of Disease Bulk and Number of Sites Involved.
Analysis or response and progression.
Measured: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startApr 2001
- Primary completion15 Mar 2007
- Study completion15 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neoplasms, MetastaticStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Milano, MD,PhD, University of Rochester
- Investigators
- Michael Milano, MD PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178399
- Sponsor's protocol ID
- URCC 9700
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2005
- Last updated
- 11 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study For Using Radiosurgery On Limited Metastases
- ClinicalTrials.gov ID
- NCT00178399
- Acronym / sponsor ID
- URCC 9700
- Conditions
- Neoplasms, Metastatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Apr 2001 (actual)
- Primary completion
- 15 Mar 2007 (actual)
- Study completion
- 15 Mar 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Posted 11 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
Detailed description
In this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Procedure: Stereotactic Body Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- KPS ≥ 70
- Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
- The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol
- Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
Key exclusion criteria (5 listed)
- Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
- Women who are pregnant or nursing..
- Failure to meet inclusion requirements
- Contraindications to radiation.
- Patient should not be eligible for primary disease specific radiosurgical protocols
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 Body Radiation Therapy | Procedure or surgery | Stereotactic body radiation therapy |
Primary outcome
Percentage of Curatively Treated Patients With Progression-free Survival
Time frame: 24 months
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Percentage of Palliatively Treated Patients With Progression-free Survival
Time frame: 24 months
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
2 secondary outcomes
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
Time frame: 30 months from date of registration.
Analyze Impact of Disease Bulk and Number of Sites Involved.
Time frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Milano, MD PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiation Therapy in people with Neoplasms, Metastatic, run by University of Rochester 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 5 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 11 Oct 2018. 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?
Yes. Results are posted in the registry (first posted 11 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Curatively Treated Patients With Progression-free Survival (time frame: 24 months). The study lists 2 primary outcomes in all. 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 11 Oct 2018.