| ID | Type | Description | Link |
|---|---|---|---|
| RPCI I-31104 |
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RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium and cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them before and after surgery may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and cisplatin before and after surgery works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients with progressive disease after completion of neoadjuvant chemotherapy are followed every 6 months. All other patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study over 6.5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
| |
| pemetrexed disodium |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologically Complete Response | Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail. | 1 year |
| Overall Survival |
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DISEASE CHARACTERISTICS:
Microscopically confirmed non-small cell lung cancer
Meets 1 of the following criteria:
No metastatic disease except peribronchial/hilar lymph nodes (N1) or ipsilateral/subcarinal mediastinal lymph nodes (N2)
No malignant pleural effusion
No exudative effusion, defined by 1 of the following criteria:
No more than 1 area of fludeoxyglucose (FDG) uptake outside the area of the primary lung tumor OR evidence of malignant pleural disease as evidenced by pleural nodules by PET scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Grace K. Dy, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Chemotherapy | Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Given IV |
|
| adjuvant therapy | Procedure | Metastasis prevention/control |
|
| conventional surgery | Procedure | Undergoing tissue removal |
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| neoadjuvant therapy | Procedure | Tumor Reduction |
|
Overall survival was defined as time from date of treatment initiation until date of death due to any cause.
| Every 6 months until the time of death up to 126 months |
| Disease Free Survival | Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first. | At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months |
| Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT | 1 year |
| Percent Change in SUV Level Between Pre and Post Chemotherapy | Percent change of PET/SUV levels between baseline and post-chemotherapy. | Baseline and post-chemotherapy |
| COMPLETED |
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| NOT COMPLETED |
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All treated and eligible patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Chemotherapy | Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pathologically Complete Response | Pathologic Complete Response is defined by a surgical pathology specimen, which is free of all gross and microscopic evidence of viable tumor. | ll treated and eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
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| Secondary | Number of Participants With Adverse Events | Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Please refer to the adverse event reporting for more detail. | All treated and eligible patients | Posted | Count of Participants | Participants | 1 year |
|
| |||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as time from date of treatment initiation until date of death due to any cause. | All treated and eligible patients | Posted | Median | 95% Confidence Interval | months | Every 6 months until the time of death up to 126 months |
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| ||||||||||||||||||||||||||
| Secondary | Disease Free Survival | Progressive disease is defined as at least a 20% increase in the sum of the longest diameter of target lesions or the appearance of new lesions. Disease Free Survival was defined as time from date of treatment initiation until date of first documented progression or date of death from any cause, whichever came first. | All treated and eligible patients | Posted | Median | 95% Confidence Interval | months | At least every 3 months after the completion of adjuvant therapy for two years and thereafter every 6 months for 3 years and then yearly up to 126 months |
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| Secondary | Correlation Between Response and Markers Such as Presence or Absence of ERCC1 and DHFR, TS, DPD and GARFT | No participants were analyzed as there was no budget left to do the analysis. | Posted | 1 year |
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| ||||||||||||||||||||||||||||||
| Secondary | Percent Change in SUV Level Between Pre and Post Chemotherapy | Percent change of PET/SUV levels between baseline and post-chemotherapy. | All treated and eligible patients | Posted | Mean | Standard Deviation | Percentage change in SUV level | Baseline and post-chemotherapy |
|
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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 | Neoadjuvant Chemotherapy | Patients receive pemetrexed disodium IV over 10 minutes followed by cisplatin IV over approximately 1 hour on day 1. Treatment repeats every 21 days for 3 courses cisplatin: Given IV pemetrexed disodium: Given IV adjuvant therapy: Metastasis prevention/control conventional surgery: Undergoing tissue removal neoadjuvant therapy: Tumor Reduction | 14 | 38 | 37 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Empyema | Infections and infestations | Systematic Assessment |
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| Infection | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Spinal fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
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| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Subcutaneous emphysema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
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| Ear congestion | Ear and labyrinth disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Eye discharge | Eye disorders | Systematic Assessment |
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| Eye irritation | Eye disorders | Systematic Assessment |
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| Lacrimation increased | Eye disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Ileus paralytic | Gastrointestinal disorders | Systematic Assessment |
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| Lip pain | Gastrointestinal disorders | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Reflux gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Reflux oesophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Asthenia | General disorders | Systematic Assessment |
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| Chest discomfort | General disorders | Systematic Assessment |
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| Chest pain | General disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Feeling jittery | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Candidiasis | Infections and infestations | Systematic Assessment |
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| Influenza | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Suture related complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | Systematic Assessment |
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| Haemoglobin | Investigations | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Balance disorder | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Vocal cord paresis | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Panic attack | Psychiatric disorders | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinusitis noninfective | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Hot flush | Vascular disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| 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 |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000068437 | Pemetrexed |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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