Bone Metastases
Conditions
Keywords
Bone metastases, Hypofractionated Radiation Therapy, Standard Radiation Therapy, XRT, Pain control, Palliation of symptoms, Questionnaire, Survey
Brief summary
The goal of this clinical research study is to learn if 1 large dose of radiation therapy is better at controlling pain from cancer that has spread to the bones than 10 smaller doses of radiation. Researchers also want to learn if 1 large dose of radiation therapy can help decrease the use of drugs to control the pain, and if it can help to control the disease.
Detailed description
Study Groups: If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group. If you are in Group 1, you will receive 1 radiation treatment a day for 10 days in a row (not counting weekends or holidays). You will receive a higher total dose of radiation than Group 2. If you are in Group 2, you will receive 1 radiation treatment given on 1 day. Radiation Therapy: You will lie on a table for the radiation treatment(s). Each treatment will last about 30 minutes. Length of Treatment: You may receive 1 or 10 radiation treatments, depending on which group you are in. You will no longer be able to receive radiation therapy if intolerable side effects occur or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. Follow-Up Visits: At Months 3, 6, 9, 12 and every 3 to 6 months after the start of radiation therapy, you will have x-rays, a bone scan, CT scan, or MRI to check the status of the disease. At Months 3, 4, and 6 and then every 3 months after that for at least 3 years, you will complete the questionnaires about the pain, your pain relief, and your quality of life. The questionnaires can be filled out at a clinic visit or sent back in the mail. This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. It is investigational to compare the number and size of radiation doses. Up to 300 participants will take part in this multicenter study. Up to 300 participants will be enrolled at MD Anderson.
Interventions
RADIATIONHypofractionated Radiation Treatment
Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.
RADIATIONOne Radiation Treatment
12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV).
BEHAVIORALQuestionnaire
Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a pathologic diagnosis of malignancy 2. Patients with any radiographic evidence of bone metastases, including plain x-ray, bone scan, computed tomography (CT) scan, magnetic resonance imaging (MRI), or positron emission tomography (PET) scan 3. Patients with pain or dysaesthesia 4. Patients with a life expectancy of more than 3 months 5. Patients able to complete pain assessment and quality of life surveys 6. Patients with multiple osseous sites are eligible; however should not treat more than 3 separate radiation treatment fields concurrently. 7. Patients with surgery for osseous metastases are allowed.
Exclusion criteria
1. Patients with prior radiation therapy to the treatment site 2. Patients with a current, untreated spinal cord compression 3. Patients with a radiographic or pathologic fracture to the treatment site 4. Patients with painful metastases to hands and feet that need to be radiated on protocol 5. Patients previously treated with radioactive isotope (e.g. Sr89) within 30 days of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Intent- to- Treat Patients With Pain Response by Treatment | From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months | Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Statistical tests in treatment group were based on the Wilcoxon rank sum test to compare changes in pain scores and analgesic use at each assessment point relative to baseline. Increases or decreases of 2 or more points on a scale of 0 to 10 indicated improving or worsening pain. Fisher exact tests were used to compare the distribution of pain responders (CR + PR) and nonresponders (PP + IR). |
| Number of Evaluable Participants With Pain Response by Treatment | From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months | Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Complete response (CR) is a pain score of 0 at the treated site and no increase in analgesic. Partial response (PR): reduction in pain score of 2 or more points above baseline with no increase in analgesic. Pain progression (PP): Increases of 2 or more points on a scale of 0 to 10 or worsening pain. indeterminate response (IR): were all other responses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Toxicity Associated With Treatment | From date of registration until the date of documented death from any cause, or lost to follow up, whichever came first, assessed up to 2 years. | Report grade 3 acute (skin, fatigue, flare reaction) and long term (sclerosis, bone ossification, bone fracture rate) toxicity associated with treatment. During radiotherapy, the patient will be examined weekly and acute reactions recorded and toxicity occurring after 3 months of radiation therapy. |
Countries
United States
Participant flow
Recruitment details
There was total 167 patients enrolled in this phase II 2013-0640 palliation of symptoms study. Eligible criteria: pathologic diagnosis of malignancy; any radiographic evidence of bone metastases; with pain or dysathesia; life expectancy of more than 3 months; should not treat more than 3 separate radiation treatment fields concurrently.
Pre-assignment details
A total of 167 patients were consented to this study, but 1 patient withdrew consent prior to protocol treatment, 3 patients insurance denied, 2 Patient condition deteriorated, 1 Pathologic fracture on reevaluation, only 160 patients was randomized and treated under this protocol.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) 3 Gy x 10 fractions; Patients can be treated with 2-D, 3-D, or intensity modulated radiation therapy (IMRT) | 79 |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) 12 Gy x 1 fraction or 16 Gy x 1 fractions, depending on the size of the metastases or gross tumor volume (GTV), treated with 2-D, 3-D, or IMRT | 81 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Incomplete radiotherapy | 3 | 0 |
| Overall Study | ineligible | 0 | 3 |
| Overall Study | Insurance denied for single-fraction treatment | 0 | 5 |
| Overall Study | Repeat imaging showed no disease | 2 | 0 |
| Overall Study | Returned home, local radiotherapy | 3 | 0 |
| Overall Study | Treatment was to >3 radiotherapy fields | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 39 Participants | 84 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 40 Participants | 76 Participants |
| Age, Continuous | 63 years | 63 years | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 4 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 73 Participants | 69 Participants | 142 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 6 Participants | 7 Participants |
| Karnofsky performance score (KPS) KPS 50-60 | 9 Participants | 10 Participants | 19 Participants |
| Karnofsky performance score (KPS) KPS 70-80 | 57 Participants | 58 Participants | 115 Participants |
| Karnofsky performance score (KPS) KPS 90-100 | 15 Participants | 11 Participants | 26 Participants |
| Number of Lesions ≤4 | 42 Participants | 41 Participants | 83 Participants |
| Number of Lesions >4 | 39 Participants | 38 Participants | 77 Participants |
| Numbers of Sites Irradiated 1 | 61 Participants | 64 Participants | 125 Participants |
| Numbers of Sites Irradiated >1 | 20 Participants | 15 Participants | 35 Participants |
| Primary Cancer Site Adrenal-cortical | 0 Participants | 1 Participants | 1 Participants |
| Primary Cancer Site Bladder | 3 Participants | 4 Participants | 7 Participants |
| Primary Cancer Site Breast | 11 Participants | 3 Participants | 14 Participants |
| Primary Cancer Site Esophagus | 4 Participants | 4 Participants | 8 Participants |
| Primary Cancer Site Head and Neck | 2 Participants | 1 Participants | 3 Participants |
| Primary Cancer Site Liver | 3 Participants | 0 Participants | 3 Participants |
| Primary Cancer Site Lung | 32 Participants | 47 Participants | 79 Participants |
| Primary Cancer Site Multiple Myeloma | 1 Participants | 1 Participants | 2 Participants |
| Primary Cancer Site Pancreas | 1 Participants | 0 Participants | 1 Participants |
| Primary Cancer Site Prostate | 14 Participants | 9 Participants | 23 Participants |
| Primary Cancer Site Renal Cell | 9 Participants | 5 Participants | 14 Participants |
| Primary Cancer Site Thymoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Cancer Site Thyroid | 0 Participants | 2 Participants | 2 Participants |
| Primary Cancer Site Unknown/Lung | 1 Participants | 0 Participants | 1 Participants |
| Primary Cancer Site Uveal Melanoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Adenocarcinoma | 51 Participants | 50 Participants | 101 Participants |
| Primary Tumor Histology Adenoid Cystic | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Adrenal Cortical Carcinoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Atypical Carcinoid | 1 Participants | 1 Participants | 2 Participants |
| Primary Tumor Histology Carcinoma | 1 Participants | 1 Participants | 2 Participants |
| Primary Tumor Histology Clear Cell | 9 Participants | 5 Participants | 14 Participants |
| Primary Tumor Histology Ductal Carcinoma | 4 Participants | 0 Participants | 4 Participants |
| Primary Tumor Histology Lobular Carcinoma | 1 Participants | 1 Participants | 2 Participants |
| Primary Tumor Histology Melanoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Neuroendocrine | 3 Participants | 1 Participants | 4 Participants |
| Primary Tumor Histology Other | 2 Participants | 1 Participants | 3 Participants |
| Primary Tumor Histology Papillary | 0 Participants | 2 Participants | 2 Participants |
| Primary Tumor Histology Pleiomorphic Carcinoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Poorly Diff Carcinoma | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Sarcomatoid | 0 Participants | 1 Participants | 1 Participants |
| Primary Tumor Histology Small Cell | 3 Participants | 1 Participants | 4 Participants |
| Primary Tumor Histology Squamous | 5 Participants | 6 Participants | 11 Participants |
| Primary Tumor Histology Urothelial Carcinoma | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 10 Participants | 18 Participants |
| Race (NIH/OMB) White | 68 Participants | 59 Participants | 127 Participants |
| Region of Enrollment United States | 81 participants | 79 participants | 160 participants |
| Sex: Female, Male Female | 32 Participants | 32 Participants | 64 Participants |
| Sex: Female, Male Male | 49 Participants | 47 Participants | 96 Participants |
| Site of Bony Mets Abdomen | 3 Participants | 4 Participants | 7 Participants |
| Site of Bony Mets Extremities | 15 Participants | 13 Participants | 28 Participants |
| Site of Bony Mets Head/Neck | 4 Participants | 2 Participants | 6 Participants |
| Site of Bony Mets Pelvis | 46 Participants | 48 Participants | 94 Participants |
| Site of Bony Mets Spine | 3 Participants | 3 Participants | 6 Participants |
| Site of Bony Mets Thorax | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 49 / 79 | 42 / 81 |
| other Total, other adverse events | 0 / 79 | 0 / 81 |
| serious Total, serious adverse events | 19 / 79 | 11 / 81 |
Outcome results
Primary
Number of Evaluable Participants With Pain Response by Treatment
Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Complete response (CR) is a pain score of 0 at the treated site and no increase in analgesic. Partial response (PR): reduction in pain score of 2 or more points above baseline with no increase in analgesic. Pain progression (PP): Increases of 2 or more points on a scale of 0 to 10 or worsening pain. indeterminate response (IR): were all other responses.
Time frame: From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 3 months | 17 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 1 month | 24 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 6 months | 17 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 9 months | 12 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 2 weeks | 19 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 9 months | 17 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 1 month | 36 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 3 months | 32 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 2 weeks | 34 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Evaluable Participants With Pain Response by Treatment | Pain Response (CR+PR) at 6 months | 19 Participants |
Comparison: Pain response Rates (CR+PR) at 2 weeksp-value: 0.01Fisher Exact
Comparison: Pain response Rates (CR+PR) at 1 monthp-value: 0.15Fisher Exact
Comparison: Pain response Rates (CR+PR) at 3 monthsp-value: 0.04Fisher Exact
Comparison: Pain response Rates (CR+PR) at 6 monthsp-value: 0.78Fisher Exact
Comparison: Pain response Rates (CR+PR) at 9 monthsp-value: 0.04Fisher Exact
Comparison: Pain response Rates (CR+PR) at 2 weeksp-value: 0.01Fisher Exact
Comparison: Pain response Rates (CR+PR) at 1 monthp-value: 0.15Fisher Exact
Comparison: Pain response Rates (CR+PR) at 3 monthsp-value: 0.04Fisher Exact
Comparison: Pain response Rates (CR+PR) at 6 monthsp-value: 0.78Fisher Exact
Comparison: Pain response Rates (CR+PR) at 9 monthsp-value: 0.04Fisher Exact
Primary
Number of Intent- to- Treat Patients With Pain Response by Treatment
Evaluate single fraction stereotactic regimen for pain response in terms of time to failure. Pain response was defined by international consensus criteria as a combination of pain score and analgesic use (daily morphine-equivalent dose). Pain failure (ie, lack of response) was defined as worsening pain score (2 points on a 0-to-10 scale), an increase in morphine-equivalent opioid dose of 50% or more, reirradiation, or pathologic fracture. Time to failure was defined as the first occurrence of any of the following events: worsening in pain score by at least 2 categories by MDASI survey. Statistical tests in treatment group were based on the Wilcoxon rank sum test to compare changes in pain scores and analgesic use at each assessment point relative to baseline. Increases or decreases of 2 or more points on a scale of 0 to 10 indicated improving or worsening pain. Fisher exact tests were used to compare the distribution of pain responders (CR + PR) and nonresponders (PP + IR).
Time frame: From date of registration until the date of first documented Pain failure or death from any cause, or lost to follow up, whichever came first, assessed up to 9 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 9 months | 12 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 2 weeks | 19 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 1 month | 24 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 3 months | 17 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 6 months | 17 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 6 months | 19 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 3 months | 31 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 2 weeks | 34 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 9 months | 17 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Intent- to- Treat Patients With Pain Response by Treatment | Pain Response (CR+PR) at 1 month | 36 Participants |
Comparison: Pain Response Rates (CR+PR) at 2 weeksp-value: 0.03Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 1 monthp-value: 0.19Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 3 monthsp-value: 0.04Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 6 monthsp-value: 0.89Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 9 monthsp-value: 0.07Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 2 weeksp-value: 0.03Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 1 monthp-value: 0.19Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 3 monthsp-value: 0.04Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 6 monthsp-value: 0.89Fisher Exact
Comparison: Pain Response Rates (CR+PR) at 9 monthsp-value: 0.07Fisher Exact
Secondary
Number of Participants With Toxicity Associated With Treatment
Report grade 3 acute (skin, fatigue, flare reaction) and long term (sclerosis, bone ossification, bone fracture rate) toxicity associated with treatment. During radiotherapy, the patient will be examined weekly and acute reactions recorded and toxicity occurring after 3 months of radiation therapy.
Time frame: From date of registration until the date of documented death from any cause, or lost to follow up, whichever came first, assessed up to 2 years.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Participants With Toxicity Associated With Treatment | Fracture | 0 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Participants With Toxicity Associated With Treatment | Fatigue | 4 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Participants With Toxicity Associated With Treatment | Vomiting | 2 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Participants With Toxicity Associated With Treatment | Radiation Dermatitis | 2 Participants |
| Arm 1: the Standard Hypofractionated Regimen (MFRT Group) | Number of Participants With Toxicity Associated With Treatment | Nausea | 4 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Participants With Toxicity Associated With Treatment | Radiation Dermatitis | 1 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Participants With Toxicity Associated With Treatment | Fracture | 1 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Participants With Toxicity Associated With Treatment | Nausea | 1 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Participants With Toxicity Associated With Treatment | Vomiting | 0 Participants |
| Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) | Number of Participants With Toxicity Associated With Treatment | Fatigue | 9 Participants |