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| ID | Type | Description | Link |
|---|---|---|---|
| US_IST_12218 | |||
| AVF3923s |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Sanofi | INDUSTRY |
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Multicenter randomized phase II trial to examine the safety and efficacy of carboplatin, docetaxel, bevacizumab followed by maintenance bevacizumab and erlotinib in patients with completely resected stage IB, II, and select III NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel/Carboplatin/Bevacizumab/Erlotinib | Experimental |
| |
| Docetaxel and Carboplatin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel/Carboplatin/Bevacizumab/Erlotinib | Drug | Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Adverse Events occuring in >15% of patients | 2 years |
| 2-year Survival | Proportion of patients known to still be alive 2 years after coming on study |
Not provided
Inclusion Criteria:
Patients must have histologically-confirmed non-small cell lung cancer (adenocarcinoma, squamous, large cell and undifferentiated). Mixed small cell and non-small histologies are excluded.
Patients with completely resected (R0) stage IB, II, and select III NSCLC. The following stages are eligible:
IB T2 N0 IIA T1 N1 IIB T2 N1 IIB T3 N0 IIIA T3 N1
Complete surgical resection defined as the appropriate pulmonary parenchymal resection including lobectomy, bilobectomy, sleeve lobectomy, and pneumonectomy with histologically confirmed negative bronchial margins. Patients treated by segmentectomy or wedge resection are not eligible for this study. Additionally all patients must have had either a mediastinal node dissection or at least, sampling of 2 mediastinal nodal stations (levels 4,7,and 9 for right-sided tumors, and levels 5,6,7, and 9 for left-sided tumors are suggested.)
No evidence of metastatic disease
ANC >= 1500, platelets >= 100,000 and hemoglobin >= 10.0.
Total bilirubin <= ULN. AST and ALT and alkaline phosphatase must be WNL
Serum creatinine <= 1.5mg/dl (If greater than 1.5, the creatinine clearance, calculated according to the Cockroft-Gault formula, must be >= 50ml/min).
Patients may have had no previous chemotherapy, radiation therapy, angiogenesis inhibitor, or tyrosine kinase inhibitor for non-small cell lung cancer.
Patients must be able to understand the nature of this study and give written informed consent.
Age >= 18 years
Ability to start treatment between 8 and 12 weeks following surgery.
Ability to take oral medication.
Exclusion Criteria:
Patients with preoperative radiologic evidence of N2 disease by either PET or CT scan (i.e. radiological evidence of metastasis to ipsilateral mediastinal and subcarinal nodes) that is confirmed as N2 disease histologically are excluded. - PLEASE SEE EXCEPTION in section 3.1.2 of protocol
Mixed small cell and non-small cell histologies
Pulmonary carcinoid tumors
Positive bronchial margins
History of prior malignancy within 5 years with the exception of skin cancer or cervical carcinoma in situ.
Women who are pregnant (positive pregnancy test) or breast-feeding. Subjects of childbearing potential or with partners of childbearing potential (women and men) must use effective birth control measures during treatment.
Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
Patients with seizures not controlled with standard medical therapy.
Patients with active infection requiring parenteral antibiotics
Patients who have had major surgical procedure, open biopsy, or significant traumatic injury within 8 weeks of beginning study treatment or anticipation of need for major surgical procedure during the course of the study
Fine needle aspiration, core biopsy or other minor surgical procedure (excluding placement of a vascular access device) within 7 days of beginning study treatment.
Patients receiving thrombolytic therapy within 10 days of starting study treatment are also ineligible. Patients may receive prophylactic anticoagulation therapy, 1 mg coumadin daily for port clot prophylaxis.
Patients with proteinuria at screening as demonstrated by either:
Patients with serious nonhealing wound, ulcer, or bone fracture.
Patients with evidence of bleeding diathesis or coagulopathy.
Patients with history of hemoptysis defined as bright red blood of ½ teaspoon or more per episode) within 8 weeks prior to study treatment.
History of myocardial infarction or unstable angina within 6 months of beginning study treatment.
Inadequately controlled hypertension (defined as systolic blood pressure > 150 and /or diastolic blood pressure > 100 mmHg on antihypertensive medications).
New York Heart Association (NYHA) grade II or greater CHF.
Serious cardiac arrhythmia requiring medication.
Symptomatic peripheral vascular disease.
History of stroke or transient ischemic attack within 6 months prior to beginning bevacizumab.
Any prior history of hypertensive crisis or hypertensive encephalopathy.
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning study treatment.
ECOG Performance status > 1.
Peripheral neuropathy> grade 1.
Known hypersensitivity to any component of study drugs including platinum or to drugs formulated with polysorbate 80.
Impaired oral absorption.
Inability to comply with study and/or follow-up procedures.
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| Name | Affiliation | Role |
|---|---|---|
| David Spigel, M.D. | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Alabama Medical Center | Anniston | Alabama | 36207 | United States | ||
| Northeast Arkansas Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel/Carboplatin/Bevacizumab/Erlotinib | Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Adjuvant Treatment |
|
Not provided
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|
| Docetaxel/Carboplatin | Drug | Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
|
| 24 months |
| Overall Survival (OS) | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | 18 months |
| Jonesboro |
| Arkansas |
| 72401 |
| United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33901 | United States |
| Gulfcoast Oncology Associates | St. Petersburg | Florida | 33705 | United States |
| Medical Oncology Associates of Augusta | Augusta | Georgia | 30901 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Wellstar Cancer Research | Marietta | Georgia | 30060 | United States |
| Providence Medical Group | Terre Haute | Indiana | 47802 | United States |
| RHHP/Hope Cancer Center | Terre Haute | Indiana | 47802 | United States |
| Baptist Hospital East | Louisville | Kentucky | 40207 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Hematology Oncology Life Center | Alexandria | Louisiana | 71301 | United States |
| Hematology Oncology Clinic, LLP | Baton Rouge | Louisiana | 70806 | United States |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Jackson Oncology Associates | Jackson | Mississippi | 39202 | United States |
| St. Louis Cancer Care | Chesterfield | Missouri | 63017 | United States |
| Nebraska Methodist Cancer Center | Omaha | Nebraska | 68114 | United States |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03801 | United States |
| Hematology Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | United States |
| New Mexico Oncology Hematology Consultants | Albuquerque | New Mexico | 87109 | United States |
| Cancer Care of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | United States |
| Associates in Hematology Oncology | Chattanooga | Tennessee | 37404 | United States |
| Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37023 | United States |
| Peninsula Cancer Institute | Newport News | Virginia | 23601 | United States |
| FG001 | Docetaxel and Carboplatin | Docetaxel/Carboplatin: Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Maintenance Treatment |
|
All patients on-study
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| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel/Carboplatin/Bevacizumab/Erlotinib | Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
| BG001 | Docetaxel and Carboplatin | Docetaxel/Carboplatin: Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
| 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, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Disease-free Survival | The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease. | Posted | Median | 95% Confidence Interval | months | 1 year |
|
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| |||||||||||||||||||||||||||||
| Secondary | Safety | Adverse Events occuring in >15% of patients | Posted | Number | participants | 2 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | 2-year Survival | Proportion of patients known to still be alive 2 years after coming on study | Posted | Number | percentage of participants | 24 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death | Posted | Median | 95% Confidence Interval | months | 18 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 | Docetaxel/Carboplatin/Bevacizumab/Erlotinib | Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. | 14 | 55 | 53 | 55 | ||
| EG001 | Docetaxel and Carboplatin | Docetaxel/Carboplatin: Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. | 14 | 57 | 55 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bronchial infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Other, hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, cholelithiasis | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, haemophilus influenza | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, pseudomona bacteremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, unspecified | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Other, hemorrhage | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders - Other, body ache | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - Other, unknown | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders - Other, unknown | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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| Male |
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