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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01482 | Registry Identifier | NCI CTRP |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Experimental | Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row. 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. |
|
| One Radiation Therapy Treatment | Active Comparator | 12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV). 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiation Treatment | Radiation | Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quynh-nhu Nguyen, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| MD Anderson Cancer Center at Cooper |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31021390 | Derived | Nguyen QN, Chun SG, Chow E, Komaki R, Liao Z, Zacharia R, Szeto BK, Welsh JW, Hahn SM, Fuller CD, Moon BS, Bird JE, Satcher R, Lin PP, Jeter M, O'Reilly MS, Lewis VO. Single-Fraction Stereotactic vs Conventional Multifraction Radiotherapy for Pain Relief in Patients With Predominantly Nonspine Bone Metastases: A Randomized Phase 2 Trial. JAMA Oncol. 2019 Jun 1;5(6):872-878. doi: 10.1001/jamaoncol.2019.0192. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | Arm 2: Single-fraction Stereotactic Radiation (SBRT Group) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 |
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|
| One Radiation Treatment | Radiation | 12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV). |
|
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| Questionnaire | Behavioral | 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. |
|
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| Voorhees Township |
| New Jersey |
| 08043 |
| United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of Lesions | Count of Participants | Participants |
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| Site of Bony Mets | Count of Participants | Participants |
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| Numbers of Sites Irradiated | Count of Participants | Participants |
| ||||||||||||||||||
| Karnofsky performance score (KPS) | KPS 100: normal activity, 90: able to carry on normal activity, 80: normal activity with effort; 70: unable to carry on normal activity; 60: Requires occasional assistance, 50: Requires frequent assistance and medical care. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome. | Count of Participants | Participants |
| |||||||||||||||||
| Primary Cancer Site | Count of Participants | Participants |
| ||||||||||||||||||
| Primary Tumor Histology | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | 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 |
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| 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. | Posted | Count of Participants | Participants | 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 |
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| 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. | Posted | Count of Participants | Participants | 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. |
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From the time of registration to the time of the adverse events (AEs) start date, assessed up to 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 49 | 79 | 19 | 79 | 0 | 79 |
| EG001 | 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 | 42 | 81 | 11 | 81 | 0 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.3) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.3) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Quynh-Nhu Nguyen, MD,Associate Professor, Radiation Oncology Department | UT MD Anderson Cancer Center | (713) 563-2450 | qnnguyen@mdanderson.org |
| Aug 18, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| >4 |
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| Thorax |
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| Extremities |
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| Head/Neck |
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| Pelvis |
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| Spine |
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| >1 |
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| KPS 70-80 |
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| KPS 90-100 |
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| Bladder |
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| Breast |
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| Esophagus |
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| Head and Neck |
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| Liver |
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| Lung |
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| Pancreas |
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| Prostate |
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| Renal Cell |
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| Thymoma |
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| Thyroid |
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| Unknown/Lung |
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| Uveal Melanoma |
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| Multiple Myeloma |
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| Adenoid Cystic |
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| Adrenal Cortical Carcinoma |
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| Atypical Carcinoid |
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| Carcinoma |
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| Clear Cell |
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| Ductal Carcinoma |
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| Lobular Carcinoma |
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| Melanoma |
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| Neuroendocrine |
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| Papillary |
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| Pleiomorphic Carcinoma |
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| Poorly Diff Carcinoma |
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| Sarcomatoid |
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| Small Cell |
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| Squamous |
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| Urothelial Carcinoma |
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| Other |
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| Pain Response (CR+PR) at 3 months |
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| Pain Response (CR+PR) at 6 months |
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| Pain Response (CR+PR) at 9 months |
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| .19 |
| Superiority |
| Pain Response Rates (CR+PR) at 3 months | Fisher Exact | .04 | Other | 2 sided p value |
| Pain Response Rates (CR+PR) at 6 months | Fisher Exact | .89 | Superiority |
| Pain Response Rates (CR+PR) at 9 months | Fisher Exact | .07 | Superiority |
| Pain Response Rates (CR+PR) at 2 weeks | Fisher Exact | .03 | Other | 2 sided p value |
| Pain Response Rates (CR+PR) at 1 month | Fisher Exact | .19 | Other | 2 sided p value |
| Pain Response Rates (CR+PR) at 3 months | Fisher Exact | .04 | Other | 2 sided p value |
| Pain Response Rates (CR+PR) at 6 months | Fisher Exact | .89 | Other | 2 sided p value |
| Pain Response Rates (CR+PR) at 9 months | Fisher Exact | .07 | Other | 2 sided p value |
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