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| Name | Class |
|---|---|
| Astellas Pharma Global Development, Inc. | INDUSTRY |
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- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Primary Objectives
- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Secondary Objectives
Exploratory Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery Followed by Erlotinib | Other | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery | Procedure | 21 Gy daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Progression Free Survival | Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions. | 3 months after Initiation of Stereostatic Radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS) | Count of subjects who had local control of sites previously progressive on erlotinib following SRS followed by erlotinib. Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), local control is defined as Complete Response (CR), Disappearance of all target lesions; or Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; in sites ablated by SRS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Weiss, MD | UNC at Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Francisco | San Francisco | California | 94115 | United States | ||
| University of Colorado Cancer Center |
Of the 32 participants who consented to the study, 5 were determined to be not eligible and 2 withdrew consent prior to starting study treatment
32 participants were accrued from six institutions between 12/2012 and 6/2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Radiosurgery Followed by Erlotinib | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Stereotactic Radiosurgery: 21 Gy daily for 5 days Erlotinib: 150mg once daily |
| 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 | Nov 18, 2014 |
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For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
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| Erlotinib | Drug | 150mg once daily |
|
|
| Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Median Overall Survival | To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant, NSCLC patients who progressed on prior EGFR-TKI therapy measured as length of time from start of treatment until date of death from any cause | up to 5 years after end of treatment |
| Toxicity Rate From Stereotactic Radiosurgery (SRS) | Toxicity of SRS will be measured by NCI CTCAE version 4 following completion of SRS, but prior to erlotinib re-initiation. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | From initiation to the end of SRS, up to 15 days |
| Toxicity Rate Attributed to Erlotinib | Toxicity of erlotinib will be graded using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE version 4) which is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | from end of SRS to end of erlotinib treatment (median duration of 5.7 months) |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| STO Taussig Cancer Center; Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Radiosurgery Followed by Erlotinib | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Stereotactic Radiosurgery: 21 Gy daily for 5 days Erlotinib: 150mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Smoking status | Count of Participants | Participants |
| ||||||||||||||||||
| Performance status | Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale from 0-5 to describe a patient's level of functioning in terms of self care ability and activity level. Higher on the scale is worse functioning | Count of Participants | Participants |
| |||||||||||||||||
| Mutation type | The mutation type is the location (Exon) of the mutation in the Epidermal Growth Factor Receptor (EGFR) gene. Subjects who did have proof of a mutation through testing (due to inadequate tissue, for example) were still eligible for the study if they met the clinical criteria of a clinical response overwhelmingly consistent with EGFR mutation (PR plus at least 6 months free of progressive disease as a consequence of EGFR-TKI therapy). | Count of Participants | Participants |
| |||||||||||||||||
| Charlson Co-morbidity Index | The Charlson Comorbidity Index is a method of categorizing comorbidities of patients in which each category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient ranging from 0 (no comorbidities) to 24. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use. | Median | Full Range | units on a scale |
|
| 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 | Percentage of Participants With Progression Free Survival | Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions. | Posted | Number | 95% Confidence Interval | percentage of participants | 3 months after Initiation of Stereostatic Radiotherapy |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS) | Count of subjects who had local control of sites previously progressive on erlotinib following SRS followed by erlotinib. Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), local control is defined as Complete Response (CR), Disappearance of all target lesions; or Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; in sites ablated by SRS. | 4 subjects were not evaluable for this outcome due to lack of follow-up measurements on ablated lesions | Posted | Count of Participants | Participants | Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
|
| |||||||||||||||||||||||||||
| Secondary | Median Overall Survival | To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant, NSCLC patients who progressed on prior EGFR-TKI therapy measured as length of time from start of treatment until date of death from any cause | Posted | Median | 95% Confidence Interval | Months | up to 5 years after end of treatment |
|
| |||||||||||||||||||||||||||
| Secondary | Toxicity Rate From Stereotactic Radiosurgery (SRS) | Toxicity of SRS will be measured by NCI CTCAE version 4 following completion of SRS, but prior to erlotinib re-initiation. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Toxicities occurring in at least two participants from SRS are reported below | Posted | Count of Participants | Participants | From initiation to the end of SRS, up to 15 days |
|
| |||||||||||||||||||||||||||
| Secondary | Toxicity Rate Attributed to Erlotinib | Toxicity of erlotinib will be graded using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE version 4) which is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. | Toxicities grade 3 or higher and attributed to erlotinib re-treatment, or toxicities occurring in at least two participants are reported below | Posted | Count of Participants | Participants | from end of SRS to end of erlotinib treatment (median duration of 5.7 months) |
|
|
From start of treatment to date of death up to 60 months
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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 | Stereotactic Radiosurgery Followed by Erlotinib | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Stereotactic Radiosurgery: 21 Gy daily for 5 days Erlotinib: 150mg once daily | 16 | 25 | 1 | 25 | 24 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Edema face | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Edema limbs | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Flashing lights | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hot flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infusion site extravasation | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nail ridging | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Papulopustular rash | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Paronychia | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin and subcutaneous tissue disorders - Other, specify | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Upper respiratory infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Watering eyes | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Weight loss | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| White blood cell decreased | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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The study closed early due to poor accrual (enrolling only 25 of 40 expected participants) and the development of second line therapy with osimertinib.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
| Sep 16, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
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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 |
|
| Unknown |
|
| Exon 19+ ALK rearrangement |
|
| Exon 18 and Exon 20 |
|
| None proven; met clinical criteria |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| None |
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