Metastatic CancerPhase 1NCT00567970
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase 1 study testing quality-of-life assessment and stereotactic body radiation therapy in people with Metastatic Cancer, run by Mayo Clinic at 1 site in United States.
Trial summary
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- quality-of-life assessment and stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2007to 21 Apr 2016
- Phase
- Phase 1
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Metastatic liver lesion ≤ 5 cm in dimension
- Willing and able to undergo percutaneous placement of localization seeds
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 75,000/µL
- Hemoglobin ≥ 9 g/dL
- ANC ≥ 1,500/mL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST ≤ 3 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to complete questionnaires alone or with assistance
- No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol
PRIOR CONCURRENT THERAPY:
- No prior radiation therapy to the liver
- No chemotherapy ≤ 4 weeks prior to registration
- Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks [4 weeks prior to and 4 weeks after registration] surrounding stereotactic radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
About this study
Official title: A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
Read the detailed description
OBJECTIVES:
- To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
- To determine the toxicity and adverse events profile of this patient population.
- To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.
OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).
Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.
Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.
After completion of study treatment, patients are followed for at least 8 weeks.
- Conditions
- Metastatic Cancer
- Being tested
- quality-of-life assessment, stereotactic body radiation therapy
- Keywords
- 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.
quality-of-life assessmentProcedure or surgery
stereotactic body radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Secondary outcomes (5)
Toxicity profile
Adverse events profile
Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
Response profile
Physical exam results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study start2 Apr 2007
- Primary completion2 Feb 2009
- Study completion21 Apr 2016
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 Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura A. Vallow, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567970
- Sponsor's protocol ID
- CDR0000579232
- Other IDs
- P30CA015083, MC0642, 06-004336
- Status last verified
- Oct 2018
- First submitted
- 4 Dec 2007
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Finding Pilot Study of Stereotactic Body Radiotherapy for the Treatment of Liver Metastasis
- ClinicalTrials.gov ID
- NCT00567970
- Acronym / sponsor ID
- CDR0000579232
- Conditions
- Metastatic Cancer
- Keywords
- liver metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Apr 2007 (actual)
- Primary completion
- 2 Feb 2009 (actual)
- Study completion
- 21 Apr 2016 (actual)
- First posted
- 5 Dec 2007 (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 radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
Detailed description
OBJECTIVES:
- To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
- To determine the toxicity and adverse events profile of this patient population.
- To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.
OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs > 5).
Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.
Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.
After completion of study treatment, patients are followed for at least 8 weeks.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| quality-of-life assessment | Procedure or surgery | – |
| stereotactic body radiation therapy | Radiation | – |
Primary outcome
Maximum tolerated dose
5 secondary outcomes
Toxicity profile
Adverse events profile
Quality of life as measured by the Brief Pain Inventory and Brief Fatigue Inventory
Response profile
Physical exam results
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 9 Oct 2018.
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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.
Laura A. Vallow, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quality-of-life assessment and stereotactic body radiation therapy in people with Metastatic Cancer, run by Mayo Clinic 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?
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 9 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose. 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 9 Oct 2018.