Unspecified Adult Solid TumorPhase 1/2NCT00938457
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases
A Phase 1/2 study testing stereotactic radiation therapy, implanted fiducial-based imaging and cone-beam computed tomography in people with Unspecified Adult Solid Tumor, 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/II 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
- Unspecified Adult Solid Tumor
- What is being tested?
- stereotactic radiation therapy, implanted fiducial-based imaging and cone-beam computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2011
- Phase
- Phase 1/2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy).
- One to three metastatic liver lesions =< 5 cm in dimension.
- Intrahepatic cholangiocarcinoma is acceptable for inclusion.
- Zubrod Performance Status (PS) 0 or 1.
- Please contact study investigator and/or consult protocol document for specific details on laboratory criteria.
- Life expectancy >= 12 weeks.
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- MELD (Model for End-Stage Liver Disease) score =< 16.
- >= 1000 cc of uninvolved liver parenchyma as determined by the treating physician.
- Determination that the patient is medically inoperable and/or unwilling to undergo liver resection in patients with colorectal carcinoma histology.
- Provide informed written consent.
- Willingness to return to Mayo Clinic Rochester for follow-up.
Who cannot join
- Pregnant women.
- Nursing women.
- Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception.
- Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm =< 7 days prior to registration.
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- Administration of chemotherapy within 2 wks prior to or 2 wks following SF-SBRT.
- Prior radiation therapy to the liver Untreated malignant biliary obstruction (patients treated successfully with stenting are eligible).
- Current diagnosis of hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases
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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
Read the detailed description
OUTLINE: This is a phase I/II, dose-escalation study.
Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
- Conditions
- Unspecified Adult Solid Tumor
- Being tested
- stereotactic radiation therapy, implanted fiducial-based imaging, cone-beam computed tomography
- Keywords
- protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic radiation therapyRadiation
Patients undergo stereotactic body radiation therapy
implanted fiducial-based imagingProcedure or surgery
radiation therapy treatment planning
cone-beam computed tomographyProcedure or surgery
radiation therapy treatment planning
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement. Receives: Radiation: stereotactic radiation therapy; Procedure: implanted fiducial-based imaging; Procedure: cone-beam computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
Measured: 2 months
Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)
LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.
Measured: At 1 year
Secondary outcomes (8)
Toxicity and Adverse Events Profile (Phase I)
Number of patients with a grade >= 3 adverse event.
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.
Description of Grades:
Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death
Measured: Up to 2 years
Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)
Measured: Up to 2 years
Radiographic Response Rate (Phase II)
Measured: Up to 2 years
Local Control (LC) Cumulative Incidence Rates (Phase II)
Measured: 3 and 6 months and 1, 2, and 5 years
Median Time to Progression of Treated Tumors (Phase II)
Measured: Up to 5 years
Refinement of Toxicity and Adverse Events Profile (Phase II)
Measured: Up to 2 years
Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)
Measured: Up to 2 years
Evaluation of Cause of Death (Phase II)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionApr 2011
Why it stopped: poor accrual
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 Unspecified Adult Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert C. Miller, M.D., Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938457
- Sponsor's protocol ID
- MC0941
- Other IDs
- MC0941, 09-000020, NCI-2009-01150
- Status last verified
- Oct 2015
- First submitted
- 9 Jul 2009
- Last updated
- 19 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose-Finding Study of Single-Fraction Stereotactic Body Radiotherapy (SF-SBRT) for the Treatment of Liver Metastases
- ClinicalTrials.gov ID
- NCT00938457
- Acronym / sponsor ID
- MC0941
- Conditions
- Unspecified Adult Solid Tumor
- Keywords
- protocol specific
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Posted 9 Jul 2012
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/II trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.
Detailed description
OUTLINE: This is a phase I/II, dose-escalation study.
Phase I: Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Phase II: Patients undergo treatment as in phase I at the maximum tolerated dose. After completion of study treatment, patients will be followed at weeks 4 and 12 and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: stereotactic radiation therapy, Procedure: implanted fiducial-based imaging, Procedure: cone-beam computed tomographyPatients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological confirmation (any histology except lymphoma, leukemia, or hepatocellular carcinoma) of at least one liver lesion that is synchronous to the primary diagnosis of malignancy or metachronous as a recurrence/metastasis or as a failure following previous therapy (except radiotherapy).
- One to three metastatic liver lesions =< 5 cm in dimension.
- Intrahepatic cholangiocarcinoma is acceptable for inclusion.
- Zubrod Performance Status (PS) 0 or 1.
- Please contact study investigator and/or consult protocol document for specific details on laboratory criteria.
Key exclusion criteria (9 listed)
- Pregnant women.
- Nursing women.
- Men or women of childbearing potential or their partners who are unwilling to employ adequate contraception.
- Co-morbid systemic illnesses or other severe concurrent disease, defined as those which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 radiation therapyPatients undergo stereotactic body radiation therapy | Radiation | Arm I |
| implanted fiducial-based imagingradiation therapy treatment planning | Procedure or surgery | Arm I |
| cone-beam computed tomographyradiation therapy treatment planning | Procedure or surgery | Arm I |
Primary outcome
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases.
Time frame: 2 months
Determine the Minimum Effective Dose (MED) Necessary for Durable Local Control, Defined as the Dose Level at Which Local Control (LC) is >= 80% at 1 Year. (Phase II)
Time frame: At 1 year
LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.
8 secondary outcomes
Toxicity and Adverse Events Profile (Phase I)
Time frame: Up to 2 years
Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase I)
Time frame: Up to 2 years
Radiographic Response Rate (Phase II)
Time frame: Up to 2 years
Local Control (LC) Cumulative Incidence Rates (Phase II)
Time frame: 3 and 6 months and 1, 2, and 5 years
Median Time to Progression of Treated Tumors (Phase II)
Time frame: Up to 5 years
Refinement of Toxicity and Adverse Events Profile (Phase II)
Time frame: Up to 2 years
Refinement of Patient Clinical Response and Treatment Effects on Blood Chemistry and Hepatic Function Markers (Phase II)
Time frame: Up to 2 years
Evaluation of Cause of Death (Phase II)
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
- 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.
Robert C. Miller, M.D. study chair
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 1/2 study testing stereotactic radiation therapy, implanted fiducial-based imaging and cone-beam computed tomography in people with Unspecified Adult Solid Tumor, 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?
The sponsor lists 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 19 May 2016. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 9 Jul 2012). 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?
Determination of the Maximum Tolerated Dose (MTD) of Single-fraction Stereotactic Body Radiation Therapy (SF-SBRT) in Hepatic Metastases. (time frame: 2 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 19 May 2016.