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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
| The Miriam Hospital | OTHER |
| Bayer | INDUSTRY |
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In this study patient's will receive the medicine Xofigo which is a radioactive drug that is FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously been tested to treat lung cancer that has spread to the bones. Your doctors are studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones.
In this study patient's will receive the medicine Xofigo which is a radioactive drug that is FDA approved to treat prostate cancer that has spread to the bones. Xofigo has not previously been tested to treat lung cancer that has spread to the bones. Your doctors are studying the effects, good and bad, of Xofigo when used to treat lung cancer that has spread to the bones. Your doctors will also be evaluating changes in health related quality of life using the EORC QL-C20 and QOL-BM22 questionnaires. They will also evaluate the impact of treatment on the Alkaline phosphate levels (by way of lab draws) in patients and measure the progression free survival and overall survival of patients with stable or responding disease after the front line chemotherapy treated with Xofigo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xofigo | Experimental | Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xofigo | Biological | This is a radio-isotope |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases | Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases | Approximately every 2 months for up to a year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo | To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding | During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Safran, MD | BrUOG Study Chair | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital and The Miriam Hospital | Providence | Rhode Island | 02903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Xofigo | Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Xofigo | Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Symptomatic Skeletal Events (SSE) in Patients Receiving Xofigo With NSCLC and Bone Metastases | Number of Participants with Symptomatic Skeletal Events (SSE) Receiving Xofigo With NSCLC and Bone Metastases | Posted | Number | Number of participants experiencing SSE | Approximately every 2 months for up to a year |
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Any serious adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation must be reported.
Any adverse event occurring after the patient has provided informed consent and until 4 weeks (30 days +1 week) after the patient has stopped study participation were captured.
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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 | Xofigo | Xofigo, 50 kBq/kg body weight, will be administered in the nuclear medicine department as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. Xofigo: This is a radio-isotope |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin (hypo) | Investigations | CTCAE version 4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kayla Rosati | Brown University Oncology Research Group (BrUOG) | 14018633000 | kayla_rosati@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2016 | Mar 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2016 | Apr 27, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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| Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo | To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo | During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | 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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| Secondary | Progression-free Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo | To measure progression-free survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo. Post 1 year of follow up the number of patients that remain stable or responding | Post 1 year of follow up the number of patients that remain stable or responding | Posted | Count of Participants | Participants | During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment |
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|
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| Secondary | Overall Survival of Patients With NSCLC and Bone Metastases and Stable or Responding Disease After Front-line Chemotherapy Treated With Xofigo | To measure overall survival of patients with NSCLC and bone metastases and stable or responding disease after front-line chemotherapy treated with Xofigo | Posted | Count of Participants | Participants | During treatment (6 cycles, 1 cycle=4 weeks) and through 1 year post treatment |
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| 0 |
| 5 |
| 0 |
| 5 |
| 5 |
| 5 |
| ANC | Investigations | CTCAE version 4 | Systematic Assessment |
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| Anorexia | Investigations | CTCAE version 4 | Systematic Assessment |
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| Bilateral Leg Cramps | Investigations | CTCAE version 4 | Systematic Assessment |
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| Dehydration | Investigations | CTCAE version 4 | Systematic Assessment |
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| Diarrhea | Investigations | CTCAE version 4 | Systematic Assessment |
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| Dizziness | Investigations | CTCAE version 4 | Systematic Assessment |
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| Eye disorder other ( kaleidoscope vision) | Investigations | CTCAE version 4 | Systematic Assessment |
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| Fatigue | Investigations | CTCAE version 4 | Systematic Assessment |
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| flatulence | Investigations | CTCAE version 4 | Systematic Assessment |
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| HGB | Investigations | CTCAE version 4 | Systematic Assessment |
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| HTN | Investigations | CTCAE version 4 | Systematic Assessment |
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| Insomnia | Investigations | CTCAE version 4 | Systematic Assessment |
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| Lymph | Investigations | CTCAE version 4 | Systematic Assessment |
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| Menorrhagia | Investigations | CTCAE version 4 | Systematic Assessment |
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| NA (hypo) | Investigations | CTCAE version 4 | Systematic Assessment |
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| nausea | Investigations | CTCAE version 4 | Systematic Assessment |
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| Oral Hemorrhage | Investigations | CTCAE version 4 | Systematic Assessment |
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| Pain (back, R hip, Ribs ) | Investigations | CTCAE version 4 | Systematic Assessment |
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| PLT | Investigations | CTCAE version 4 | Systematic Assessment |
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| WBC | Investigations | CTCAE version 4 | Systematic Assessment |
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| weight gain | Investigations | CTCAE version 4 | Systematic Assessment |
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| Dyspnea | Investigations | CTCAE version 4 | Systematic Assessment |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |