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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000389508 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery.
PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiation, Surgery, Chemotherapy | Experimental | Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction Carboplatin | Drug |
| ||
| Induction Paclitaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Mediastinal Nodal Clearance Rate | If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error. | At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy | Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen. | At time of surgery (16-18 weeks) |
| Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery |
Not provided
Inclusion Criteria:
Patients with Stage IIIA (T1-3 N2) or Stage IIIB (N3, excluding supraclavicular involvement) non-small cell lung cancer documented by biopsy or cytology (Pancoast tumors are eligible if pathologic evidence of mediastinal nodal disease is present);
Disease must be measurable;
Mediastinal lymph nodes must be proven positive by pathologic review. All patients must undergo mediastinoscopy, thoracoscopy, Chamberlain procedure, or transbronchial needle aspirate to evaluate extent of nodal involvement. Any lymph node assessed by mediastinoscopy and found to be positive will be defined as N2 disease;
Patients ≥ 18 years of age;
Life expectancy ≥ 6 months;
Zubrod performance status 0- 1 (See Appendix II);
Pretreatment laboratory values must be as follows: White blood cell count (WBC) count: ≥ 3,000/mm^3; Absolute granulocyte count: ≥ 1,500/mm^3; Platelets: ≥ 100,000/mm3; Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN); Serum creatinine: ≤ 1.5 x institutional ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; serum albumin: ≥ 3.0 g/dL
Baseline forced expiratory volume (FEV1) must be at least 2.0 liters; if less than 2.0 then V/Q scan is required and projected post-operative FEV1 must be > 800 cc based on the following formula using the quantitative Ventilation/perfusion (V/Q) scan: FEV1 = FEV1 x % perfusion to uninvolved lung from quantitative lung V/Q scan report.
Patient evaluation and acceptance by thoracic surgery, medical oncology, and radiation oncology; patient must be a potential surgical candidate prior to the initiation of therapy;
Women of childbearing potential and male participants must practice an effective method of contraception during the study;
Pretreatment evaluations required for eligibility include:
Patients must sign a study-specific informed consent prior to study entry.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohan Suntharalingam, MD | University of Maryland Greenebaum Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Services Foundation | Phoenix | Arizona | 85013 | United States | ||
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22543206 | Result | Suntharalingam M, Paulus R, Edelman MJ, Krasna M, Burrows W, Gore E, Wilson LD, Choy H. Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):456-63. doi: 10.1016/j.ijrobp.2011.11.069. Epub 2012 Apr 28. | |
| Result | Suntharalingam M, Paulus R, Edelman MJ, et al.: RTOG 0229: A phase II trial of neoadjuvant therapy with concurrent chemotherapy and high-dose radiotherapy (XRT) followed by resection and consolidative therapy for LA-NSCLC. [Abstract] J Clin Oncol 28 (Suppl 15): A-7024, 2010. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemoradiation, Surgery, Chemotherapy | Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Resection | Procedure |
|
| Consolidation Carboplatin | Drug |
|
| Radiation Therapy | Radiation |
|
| Consolidation Paclitaxel | Drug |
|
The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death. |
| From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration) |
| Percentage of Patients Able to Undergo Surgical Resection | At time of surgery (16-18 weeks) |
| Distribution of R0, R1, and R2 Resections After Chemotherapy | An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection. | At time of surgery (16-18 weeks) |
| Overall Survival at Two Years | Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | From registration to two years |
| Progression-free Survival at Two Years | Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method. | From registration to two years |
| Distribution of Highest Grade Adverse Event | The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented. | From start of treatment to end of follow-up, a maximum of 64.3 months |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90089-9181 | United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308 | United States |
| Cancer Institute at St. John's Hospital | Springfield | Illinois | 62702 | United States |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St Louis | Missouri | 63110 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| Cancer Institute of New Jersey at Cooper University Hospital - Camden | Camden | New Jersey | 08103 | United States |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees Township | New Jersey | 08043 | United States |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville | North Carolina | 27835-6028 | United States |
| St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem | Pennsylvania | 18015 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee | Wisconsin | 53295 | United States |
| Eligible |
|
| Eligible and Underwent Surgery |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients who started protocol treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemoradiation, Surgery, Chemotherapy | Chemoradiation, surgery, chemotherapy carboplatin paclitaxel adjuvant therapy conventional surgery neoadjuvant therapy radiation therapy |
| 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 |
|
| 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 | Mediastinal Nodal Clearance Rate | If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error. | Eligible patients who had adequate pathologic information of mediastinal nodal status. | Posted | Number | participants | At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks. |
|
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy | Complete pathologic response is defined as complete resection achieved and no evidence of viable tumor in the entire resection specimen. | Eligible patients who underwent surgery | Posted | Number | 95% Confidence Interval | percentage of participants | At time of surgery (16-18 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Major Surgical Morbidities Within 30 Days of Surgery | The surgical morbidities occurring within 30 days following resection were assessed and graded using the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0. A major morbidity is considered a grade 3 or higher of any of the following: pneumonitis, infection, atelectasis, chest tube drainage/bronchial stump leak, pneumothorax, chylothorax, cardiac ischemia/infarction, pulmonary thrombosis/embolism, supraventricular atrial arrhythmia, ventricular arrhythmia, post-operative hemorrhage, pulmonary/upper respiratory fistula, pleural effusion, or death. | Eligible patients who underwent surgery | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 30 days following surgery (surgery occurs within 16-18 weeks after registration) |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Patients Able to Undergo Surgical Resection | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | At time of surgery (16-18 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Distribution of R0, R1, and R2 Resections After Chemotherapy | An R0 resection is defined as a complete resection of all disease with negative margins and the highest lymph node resected negative for residual tumor. An R1 resection is defined as a complete resection of all disease with pathology of positive margins, pathologic evidence of tumor cells in the highest lymph node resected in the mediastinum, or extracapsular nodal spread. An R2 resection is defined as gross residual disease left behind after surgical resection. | Eligible patients who underwent surgery | Posted | Number | 95% Confidence Interval | percentage of participants | At time of surgery (16-18 weeks) |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival at Two Years | Overall survival time is defined as time from registration to the date of death from any cause. Overall survival rate is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to two years |
|
| ||||||||||||||||||||||||||
| Secondary | Progression-free Survival at Two Years | Progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. An event for progression-free survival is the first occurrence of progression or death due to any cause. Progression-free survival time is defined as the time from study entry to the the date progression or death, or last known follow-up (censored) if neither progression nor death occurred. Progression-free survival rate is estimated using the Kaplan-Meier method. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to two years |
|
| ||||||||||||||||||||||||||
| Secondary | Distribution of Highest Grade Adverse Event | The number of patients whose highest grade adverse event (AE) reported was 3, 4, or 5 was calculated. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Number of patients with highest grade of 3, 4, and 5 are presented. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From start of treatment to end of follow-up, a maximum of 64.3 months |
|
|
Not provided
Eligible patients are included. Patients experiencing more than one of a given adverse event are counted only once for that adverse event.
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 | Chemoradiation, Surgery, Chemotherapy | Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2. | 19 | 57 | 57 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arrhythmia NOS | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ocular/visual - Other | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Abdominal distention | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Colonic obstruction | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Serum sickness | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anal infection NOS | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gingival infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Wound | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prolonged chest tube drainage or air leak after pulmonary resection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood/bone marrow - Other | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Supraventricular arrhythmia NOS | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastritis NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic): Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain - Other | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rigors | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Radiation recall syndrome | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Metabolic/laboratory - Other | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Muscle weakness NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Laryngitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prolonged chest tube drainage or air leak after pulmonary resection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pulmonary/upper respiratory - Other | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rhinitis allergic NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatology/skin - Other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Sweating increased | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hot flushes NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radiation Therapy Oncology Group (RTOG) | wseiferheld@acr.org |
| 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 |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
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