A Phase 1/2 interventional study of stereotactic radiation therapy and implanted fiducial-based imaging in Unspecified Adult Solid Tumor, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2016-05-19.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Treatment
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.
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 3 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Radiation: stereotactic radiation therapy · Procedure: implanted fiducial-based imaging · Procedure: cone-beam computed tomography
Patients undergo stereotactic body radiation therapy
radiation therapy treatment planning
radiation therapy treatment planning
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)
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.
Time frame: At 1 year
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
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
Three patients were recruited at Mayo Clinic between January 2010 and May 2010.
| Milestone | Arm I |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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
| participants | Arm I |
|---|---|
| Toxicity and Adverse Events Profile (Phase I) | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I | — | 0/3 (0%) | 2/3 (66.7%) |
| Event | Arm I |
|---|---|
| PericarditisCardiac disorders | 1/3 |
| NauseaGastrointestinal disorders | 1/3 |
| VomitingGastrointestinal disorders | 1/3 |
| Alanine aminotransferase increasedInvestigations | 1/3 |
| BilirubinInvestigations | 1/3 |
| Age, Continuous(years) | Arm I |
|---|---|
| Median | 60 (43 to 67) |
| Sex: Female, Male(Participants) | Arm I |
|---|---|
| Female | 1 |
| Male | 2 |
| Region of Enrollment(participants) | Arm I |
|---|---|
| United States | 3 |
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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