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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000371578 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Stereotactic body radiation therapy may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase II trial is studying how well stereotactic body radiation therapy works in treating patients with inoperable stage I or stage II non-small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive 3 fractions of stereotactic body radiotherapy over 8-14 days in the absence of disease progression or unacceptable toxicity.
Patients are followed up at 6 and 12 weeks, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 26 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic body radiation therapy (SBRT) | Experimental | 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation therapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Control at 2 Years | Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method. | From the start of treatment to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Specified Adverse Events | Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events:
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
The following primary cancer subtypes are eligible:
Stage I or II disease based on 1 of the following tumor node metastasis (TNM) stage criteria:
No primary tumor of any T-stage within or touching the zone of the proximal bronchial tree* NOTE: *Defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, and right and left lower lobe bronchi)
No primary T3 tumors involving the central chest (≤ 2 cm toward carina invasion) or structures of the mediastinum
Any hilar or mediastinal lymph nodes > 1 cm on CT scan OR demonstrating suspicious uptake on positron-emission tomography scan must be biopsied and confirmed negative for NSCLC
The primary tumor must be deemed technically resectable with a reasonable possibility of obtaining a gross total resection with negative margins (defined as a potentially curative resection (PCR))
Deemed medically inoperable based on pulmonary function for surgical resection of NSCLC secondary to an underlying physiological problem, including any of the following medical conditions*:
No evidence of regional or distant metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Robert D. Timmerman, MD | Simmons Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19695451 | Background | Hurkmans CW, Cuijpers JP, Lagerwaard FJ, Widder J, van der Heide UA, Schuring D, Senan S. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable Stage I-II non-small-cell lung cancer. In reply to Dr. Xiao et al. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):318; author reply 318. doi: 10.1016/j.ijrobp.2009.05.050. No abstract available. | |
| 16982540 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiation Therapy (SBRT) | 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All eligible patients who received protocol treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiation Therapy (SBRT) | 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body 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 |
| 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 | Local Control at 2 Years | Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method. | Eligible patients who started protocol treatment. | Posted | Number | 95% Confidence Interval | percentage of subjects | From the start of treatment to 2 years |
|
Not provided
Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Body Radiation Therapy (SBRT) | 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphatics - Other | Blood and lymphatic system 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 |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | Radition Therapy Oncology Group (RTOG) | wseiferheld@gmail.com |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
Not provided
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Not provided
Not provided
Not provided
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| From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years. |
| Rate of Local Recurrence at 2 Years | Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored). | From the start of treatment to 2 years |
| Rate of Regional Recurrence at 2 Years | Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method. | From the start of treatment to 2 years |
| Rate of Disseminated Recurrence at 2 Years | Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method. | From the start of treatment to 2 years |
| Rate of Disease-free Survival at 2 Years | Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. | From the start of treatment to 2 years |
| Rate of Overall Survival at 2 Years | Overall survival time is defined as time from start of treatment to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. | From the start of treatment to 2 years |
| M.D. Anderson Cancer Center at University of Texas |
| Houston |
| Texas |
| 77030-4009 |
| United States |
| Background |
| Timmerman R, Galvin J, Michalski J, Straube W, Ibbott G, Martin E, Abdulrahman R, Swann S, Fowler J, Choy H. Accreditation and quality assurance for Radiation Therapy Oncology Group: Multicenter clinical trials using Stereotactic Body Radiation Therapy in lung cancer. Acta Oncol. 2006;45(7):779-86. doi: 10.1080/02841860600902213. |
| 20233825 | Result | Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261. |
| 19251095 | Result | Xiao Y, Papiez L, Paulus R, Timmerman R, Straube WL, Bosch WR, Michalski J, Galvin JM. Dosimetric evaluation of heterogeneity corrections for RTOG 0236: stereotactic body radiotherapy of inoperable stage I-II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1235-42. doi: 10.1016/j.ijrobp.2008.11.019. |
| Result | Timmerman RD, Paulus R, Galvin J, et al.: Toxicity analysis of RTOG 0236 using stereotactic body radiation therapy to treat medically inoperable early stage lung cancer patients. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-151, S86, 2007. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Stereotactic Body Radiation Therapy (SBRT) | 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy |
|
|
|
| Secondary | Proportion of Subjects With Specified Adverse Events | Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events:
Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. | All eligible patients who started study treatment | Posted | Count of Participants | Participants | From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years. |
|
|
|
| Secondary | Rate of Local Recurrence at 2 Years | Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored). | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to 2 years |
|
|
|
| Secondary | Rate of Regional Recurrence at 2 Years | Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to 2 years |
|
|
|
| Secondary | Rate of Disseminated Recurrence at 2 Years | Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to 2 years |
|
|
|
| Secondary | Rate of Disease-free Survival at 2 Years | Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. | Eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | From the start of treatment to 2 years |
|
|
|
| Secondary | Rate of Overall Survival at 2 Years | Overall survival time is defined as time from start of treatment to the date of death from any cause. Overall survival rates are 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 the start of treatment to 2 years |
|
|
|
| 11 |
| 55 |
| 49 |
| 55 |
| Cardiac general - Other | Cardiac 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 |
|
| Chest pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Forced expiratory volume | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Metabolic/laboratory - Other | 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 |
|
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric 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 |
|
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pulmonary hypertension NOS | 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 |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Abdominal pain NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Diarrhea NOS | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Nausea | 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 |
|
| Infection with Grade 3 or 4 neutrop | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Fracture NOS | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Activated partial thromboplastin ti | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Blood alkaline phosphatase increase | 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 |
|
| Forced expiratory volume | 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 |
|
| Pulmonary function test NOS decreas | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Weight decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperglycemia NOS | 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 |
|
| Hyponatremia | Metabolism and nutrition 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 |
|
| Musculoskeletal/soft tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Renal/genitourinary - Other | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Atelectasis | 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 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pneumonitis NOS | 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 |
|
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |