Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UNC IRB 05-2091 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Radiation therapy uses high energy x-rays to kill tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with bevacizumab, radiation therapy, and erlotinib may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, open-label, controlled, phase I (closed to accrual as of 1/3/2008), dose-escalation study of bevacizumab and erlotinib hydrochloride, followed by a phase II study.
Phase I (closed to accrual as of 1/3/2008):
Induction therapy: Patients receive paclitaxel IV over 3 hours, carboplatin IV over 15-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients with stable or responding disease proceed to chemoradiotherapy.
Chemoradiotherapy: Patients receive chemoradiotherapy according to their assigned dose cohort:
Cohorts of 5 patients receive chemoradiotherapy as described above until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 (with grade 4 toxicity) or 3 (with grade 3 toxicity) of 5 patients experience dose-limiting toxicity.
Three to 6 weeks after completion of chemoradiotherapy, patients proceed to consolidation therapy.
Consolidation therapy: Patients receive bevacizumab IV on day 1 and oral erlotinib hydrochloride on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Induction therapy: Patients receive induction therapy as in phase I (closed to accrual as of 1/3/2008).
Chemoradiotherapy: Patients undergo TCRT and receive carboplatin and paclitaxel as in phase I (closed to accrual as of 1/3/2008). Patients also receive bevacizumab and erlotinib hydrochloride as in phase I (closed to accrual as of 1/3/2008) at the MTD/drug combination determined in phase I (closed to accrual as of 1/3/2008).
Consolidation therapy: Patients receive consolidation therapy as in phase I (closed to accrual as of 1/3/2008).
Tumor tissue and peripheral blood is collected at baseline for future correlative and biomarker studies.
After completion of study therapy, patients are followed every 2 months for 2 years, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
|
| Cohort 2 | Experimental | Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
|
| Cohort 3 | Experimental | Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
|
| Phase II | Experimental | Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter. | 6 weeks after completion of therapy |
| Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). | 6 weeks after completion of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
Squamous cell histology allowed provided there is no hemoptysis and no central invasive lesions that abut or invade major blood vessels in the chest (with or without cavitation)
Considered suitable and appropriate for combined modality therapy and thoracic conformal radiotherapy, as determined by the treating medical and radiation oncologist
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Stinchcombe, MD | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Thomas A. Stinchcombe, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7295 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23045594 | Result | Socinski MA, Stinchcombe TE, Moore DT, Gettinger SN, Decker RH, Petty WJ, Blackstock AW, Schwartz G, Lankford S, Khandani A, Morris DE. Incorporating bevacizumab and erlotinib in the combined-modality treatment of stage III non-small-cell lung cancer: results of a phase I/II trial. J Clin Oncol. 2012 Nov 10;30(32):3953-9. doi: 10.1200/JCO.2012.41.9820. Epub 2012 Oct 8. |
| Label | URL |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | View source |
Not provided
Of the 48 participants screened for eligibility, 46 were deemed eligible and went on to treatment, 1 was ineligible, and 1 was initially ruled eligible but the liver functioning tests (LFTs) continued to increase so the PI felt the participant should not be treated.
Participants were recruited from four institutions between February 2006 and April 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Bevacizumab 10 mg + Chemoradiotherapy |
| FG001 | Cohort 2 | Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| carboplatin | Drug | Given IV |
|
| erlotinib hydrochloride | Drug | Given orally |
|
| paclitaxel | Drug | Given IV |
|
| 3-dimensional conformal radiation therapy | Radiation | Given 5 days a week for 7 weeks |
|
| 5 years |
| Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II) | Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up. Complete Response (CR)- Disappearance of all target lesions | 5 years |
| Overall Response Rate and Survival Profile | The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression. | 5 years |
| Feasibility and Tolerability of Administering Consolidation Therapy | The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy | 6 cycles |
| Batte Cancer Center at Northeast Medical Center | Concord | North Carolina | 28025 | United States |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-1096 | United States |
| FG002 | Cohort 3 | Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy |
| FG003 | Phase II | Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy |
| Cohort Induction |
|
| Consolidation Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
| BG001 | Cohort 2 | Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
| BG002 | Cohort 3 | Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
| BG003 | Phase II | Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy) |
| BG004 | 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 |
| ||||||||||||||||
| 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 |
|
| 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 | Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008]) | Dose-limiting toxicities (DLTs) were used to establish which cohort would be used for the phase II portion of the trial. DLTs were defined as any grade 3 or 4 nonhematologic toxicity with the exception of esophagitis, which had to be grade 4; grade 4 neutropenia lasting greater than or equal to 7 days and thrombocytopenia to less than 20,000/microliter. | This was a phase I objective only, so the phase II participants are not included. | Posted | Number | DLTs | 6 weeks after completion of therapy |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy | A list of Hematologic and nonhematologic toxicities associated with induction and concurrent therapy. This includes the percentage of patients who experienced grades 2-4 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable for toxicity. 42 patients were eligible for concurrent therapy. | Posted | Number | percentage of participants | 6 weeks after completion of therapy |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | The length of time during and after the treatment of a stage IIIA/B NSCLC that a patient lives with the disease but it does not get worse. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. | Posted | Median | 95% Confidence Interval | Months | 5 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II) | Measurable lesions must be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10mm with spiral CT scan or nonmeasurable, but evaluable. Evaluable is nonmeasurable disease that includes ascites, malignant pleural/pericardial effusion, bone lesions, or marrow involvement. The same method of assessment and the same techniques should be used to characterize each identified and reported lesion at baseline and during follow-up. Complete Response (CR)- Disappearance of all target lesions | 43 of 45 patients received both cycles of induction C/P therapy plus bevacizumab. | Posted | Count of Participants | Participants | 5 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate and Survival Profile | The overall response rate (ORR) to the two cycles of induction therapy plus bevacizumab in stage IIIA/B NSCLC. ORR is the portion of patients with a tumor size reduction for a minimum time period. Response duration is measured from the time of initial response until documented tumor progression. | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. | Posted | Number | 95% Confidence Interval | percentage of participants | 5 years |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Feasibility and Tolerability of Administering Consolidation Therapy | The proportion of patients who were able to complete consolidation therapy after induction therapy and chemoradiotherapy | Of the initial 14 patients, only 9 (64%) patients were able to start consolidation therapy and only 5 (36%) patients were able to complete 6 cycles. | Posted | Count of Participants | Participants | 6 cycles |
|
|
5 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Overall Study | Of the 46 patients, one was retrospectively diagnosed as having stage IV NSCLC after induction therapy was withdrawn from the protocol therapy leaving 45 evaluable patients. This includes patients from all cohorts. | 30 | 45 | 19 | 45 | 45 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Bronchus | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC - Esophagus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC - Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - Other (Specify, __) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment | Neurotoxicity-sensory neuropathy |
|
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Burn | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac Arrhythmia - Other (Specify, __) | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cytokine release syndrome/acute infusion reaction | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Extremity-lower (gait/walking) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other (Specify, __) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Odynophagia |
|
| Glomerular filtration rate | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, GU - Bladder | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Lung | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory - Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhage/Bleeding - Other (Specify, __) | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flashes/flushes | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypopigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection - Other (Specify, __) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Esophagus |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment | e.g., graft, implant, prosthesis, stent |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Sinus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC - Esophagus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC - Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with unknown ANC - Sinus | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Injection site reaction/extravasation changes | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Joint-function | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/Laboratory - Other (Specify, __) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood alteration - Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mood alteration - Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) - Extraocular | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neurology - Other (Specify, __) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Chest/thorax NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Oral-gums | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other (Specify, __) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Pain NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Rectum | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Chemoradiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash: dermatitis associated with radiation - Radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __) | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Urinary burning |
|
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stricture/stenosis (including anastomotic), GI - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ulcer, GI - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vaginitis (not due to infection) | Reproductive system and breast disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mental Status | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal - Other (Specify,___) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment | Oral Abcess |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin V. Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | Robin_V_Johnson@med.unc.edu |
| 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 |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D016190 | Carboplatin |
| D000069347 | Erlotinib Hydrochloride |
| D017239 | Paclitaxel |
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|