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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01665 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.
PRIMARY OBJECTIVES:
I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).
II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =< 5) target lesions.
SECONDARY OBJECTIVES:
I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).
II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.
OUTLINE:
Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.
After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (MRI-guided Tri-60Co teletherapy SBRT) | Experimental | Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-Guided Adaptive Radiation Therapy | Radiation | Undergo MRI-guided Tri-60Co teletherapy SBRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plan quality of the MRI guided radiotherapy vs. conventional linac radiotherapy. | Comparing the plan quality of the MRI guided radiotherapy to conventional determined by the ability to create treatment plans that are comparable to those generated by a conventional linear accelerator, and by the treating radiation oncologist's ability to accurately visualize and align to the target lesion | Up to 2 years |
| Feasibility of SBRT delivery by the MRI-guided tri-60Co teletherapy system, calculated by recording the number of patients for whom plans were or were not comparable between the two modalities | Up to 2 years | |
| Magnitude of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system | Up to 2 years | |
| Velocity of target motion in three dimensional space as captured by real time imaging acquired by the MRI guided tri-60 Co teletherapy system | Up to 2 years | |
| Quality of real-time image guidance provided the tri-60Co system, as defined by the treating radiation oncologist's ability to visualize the target lesion using the on-board MRI | Up to 2 tears |
| Measure | Description | Time Frame |
|---|---|---|
| Collection of biomarkers that may be associated with an immunologic systemic response to SBRT | Up to 2 years | |
| DSS | Up to 2 years | |
| Frequency of acute grade 2-5 gastrointestinal toxicity graded using the Common Toxicity Criteria version 4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Raldow, MD | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Stereotactic Body Radiation Therapy | Radiation | Undergo MRI-guided Tri-60Co teletherapy SBRT |
|
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| Up to 2 years |
| Infield tumor LC | Up to 2 years |
| OS | Up to 2 years |
| Validity of automatically segmented contours generated by the MRI-guided tri-60Co teletherapy system through independent evaluation of images obtained | Up to 2 years |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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