Metastatic CancerPhase 1NCT00547677
Stereotactic Radiosurgery for Patients With Hepatic Metastases.
A Phase 1 study testing stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
RATIONALE: Stereotactic radiosurgery 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 radiosurgery 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, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2004to Dec 2008
- 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:
- Histologically confirmed primary cancer
- Stage IV primary disease with up to five liver metastases that are visualized on CT scan, MRI of the abdomen, or positron-emission tomography
- No liver metastases secondary to germ cell tumor or hematologic malignancy
- Other sites of metastases allowed
- No malignant ascites
- The cumulative total dose of radiotherapy to ≥ 2/3 of the liver and surrounding normal tissues, including the esophagus, stomach, and small bowel, must be ≤ 15 Gy
- Percutaneous or laparoscopic biopsy of the metastasis and placement of 3-5 fiducials required if undergoing Cyberknife for treatment delivery
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Life expectancy ≥ 3 months
- Albumin ≥ 3 g/dL
- Alkaline phosphatase < 1.5 times upper limit of normal (ULN)
- AST and ALT < 1.5 times ULN
- Total bilirubin < 1.5 times ULN
- Prothrombin time < 1.5 times ULN
- Hemoglobin > 10 g/dL
- Platelet count > 100,000/mm³
- ANC > 1,000/mm³
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
- No active peptic ulcer disease
- No hepato-renal syndrome
PRIOR CONCURRENT THERAPY:
- Prior systemic therapy allowed provided complete blood cell counts have recovered
- No other concurrent antineoplastic treatment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
RATIONALE: Stereotactic radiosurgery 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 radiosurgery in treating patients with liver metastases.
Read the detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in patients with hepatic metastases.
- To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.
- To assess the tumor response in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which > 33% of patients experience dose-limiting toxicity.
After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
- Being tested
- stereotactic radiosurgery
- Keywords
- liver metastases, unspecified adult solid tumor, protocol specific
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2007 (estimated)
- Study startJul 2004
- Primary completionDec 2007
- Study completionDec 2008
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 University of Texas Southwestern Medical 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert D. Timmerman, MD, Study chair, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547677
- Sponsor's protocol ID
- CDR0000571611
- Other IDs
- SCCC-062004-005
- Status last verified
- Feb 2019
- First submitted
- 19 Oct 2007
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
- ClinicalTrials.gov ID
- NCT00547677
- Acronym / sponsor ID
- CDR0000571611
- Keywords
- liver metastases, unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Oct 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 radiosurgery 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 radiosurgery in treating patients with liver metastases.
Detailed description
OBJECTIVES:
- To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in patients with hepatic metastases.
- To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.
- To assess the tumor response in these patients.
OUTLINE: This is a multicenter study.
Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which > 33% of patients experience dose-limiting toxicity.
After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
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 |
|---|---|---|
| stereotactic radiosurgery | Radiation | – |
Primary outcome
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
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 15 Feb 2019.
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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.
Robert D. Timmerman, MD study chair
Simmons Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing stereotactic radiosurgery in people with Metastatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Texas Southwestern Medical Center at 2 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?
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 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 of stereotactic radiosurgery as assessed by NCI CTCAE v3.0. 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 15 Feb 2019.