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The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).
The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction). Poor performance status patients can be a heterogeneous group, with tumor-related factors, other co-morbidities, or advanced age placing patients in the category. These patients have traditionally been underrepresented in clinical trials, and thus no prospective study has evaluated the efficacy of other radiotherapy dose fractionations in these patients. One phase III trial of "poor-risk" locally advanced NSCLC (RTOG 93-04) included just over 40% Karnofsky performance status 60-70 patients and showed median survival times of 9.5 and 10.3 months with 60Gy of conventional radiation therapy alone or with recombinant β-interferon [18]. 1 year overall survival was just 44% in these patients.
This study includes randomization to two arms. Arm A (experimental arm) will include IGRT, 60 Gy in 15 fractions (3 weeks). Arm B will include conventional radiation, 60-66 Gy in 30-33 fractions (6 weeks) with optional concurrent with carboplatin/taxol .
The experimental arm dose for this trial is based on a dose escalation trial at University of Texas Southwestern evaluating the maximum tolerated dose of hypofractionated IGRT in this patient population (Phase I study IRB #072010-050). Doses were escalated from 3 Gy per fraction (total dose 45 Gy) to 4 Gy per fraction (total dose 60 Gy) and evaluation for treatment related toxicity was being performed. Critical structure dose constraints will be expressed as organ dose-volume limits, with limits formulated with the approval of the study investigators using known tolerance data, radiobiological conversion models, and norms used in current practice at academic centers [27].
Randomization Schema:
Patients will be allocated to the treatment using a randomized permuted block within strata to balance for patient factors other than institution. The stratifying variables are Zubrod performance status (2 vs. > 2) and stage (II vs. III).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Active Comparator | Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks |
|
| Conventional Radiation | Active Comparator | Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival of Standard Radiation (CFRT) Versus Accelerated, Hypofractionated, Image-guided Conformal Radiotherapy (IGRT) in Treatment of Stage II-III NSCLC in Patients With Poor Performance Status at 1 Year. | Percentage of participants with overall survival at 1 year. To compare the efficacy by overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III or recurrent NSCLC in patients with poor performance status. Overall survival time will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in survival distributions. The Cox proportional hazard regression model will be used to determine hazard ratios and 95% confidence intervals for the treatment difference in overall survival. Unadjusted ratios and ratios adjusted for stratification variables and other covariates of interest will be computed. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicities of Two Radiotherapy Treatment Regimens in Patients With Stage II-III Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status | To compare toxicity of two radiotherapy treatment regimens in patient with stage II-III Non-Small Cell Lung Cancer (NSCLC) and poor performance status. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Puneeth Iyengar, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Puneeth Iyengar, MD | puneeth.iyengar@utsouthwestern.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown Cancer Center (Austin Cancer Center) | Austin | Texas | 78758 | United States | ||
| University of Texas Southwestern Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34383006 | Derived | Iyengar P, Zhang-Velten E, Court L, Westover K, Yan Y, Lin MH, Xiong Z, Patel M, Rivera D, Chang J, Saunders M, Shivnani A, Lee A, Hughes R, Gerber D, Dowell J, Gao A, Heinzerling J, Li Y, Ahn C, Choy H, Timmerman R. Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non-Small Cell Lung Cancer and Poor Performance Status: A Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1497-1505. doi: 10.1001/jamaoncol.2021.3186. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation Therapy | Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks |
| FG001 | Conventional Radiation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 22, 2019 |
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| Conventional radiation | Radiation | Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks |
|
| 60 months |
| Time to Local Progression of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status | The time to disease progression and time to local regression will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in PFS (progression-free survival) and time to local progression distributions. The Cox proportional hazard regression model will be used to determine hazard ratios and 95% confidence intervals for the treatment difference in progression-free survival and time to local progression. Time to progression will be measured from the date of study enrollment to the date of documented local progression as determined by clinical exam and imaging studies. | 60 months |
| Disease-free Survival of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | Percentage of patients with disease-free survival at 60 months. To compare disease-free survival of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status. Unlike progression-free survival in the advanced cancer setting, which refers to time from treatment to disease progression (or death) in patients who already have measurable cancer in their bodies, DFS (disease-free survival) refers to time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment. | 60 months |
| Quality of Life of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | Patient-reported functional status will be assessed with the lung cancer subscales of the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L is a 36-item questionnaire that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). | 6 months |
| Cost Effectiveness of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | For the primary analysis, we will estimate cost accumulated within 2 years. An inverse-probability weighting method to calculate average costs for each treatment group will be used to analyze. | 2 years |
| Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | The quality-adjusted survival time is just an integration of the utility measures over a patient's survival time, or until the time limit similar as the cost calculation, whichever occurs earlier. To estimate quality adjusted survival time, data from EQ-5D (EuroQol- 5 Dimension a descriptive system for health-related quality of life states in adults), each of which has five severity levels that are described by statements appropriate to that dimension) will first be translated into utility measures. These measures are obtained at discrete time points, so they will be interpolated into the time intervals between the visits. Accordingly, we will use the inverse-probability weighted method of Zhao and Tsiatis to carry out the survival time analysis. | 20 months |
| Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | The quality-adjusted survival time is just an integration of the utility measures over a patient's survival time, or until the time limit similar as the cost calculation, whichever occurs earlier. To estimate quality adjusted survival time, data from the VAS (visual analogue scale: the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine') of EQ-5D (EuroQol- 5 Dimension a descriptive system for health-related quality of life states in adults), each of which has five severity levels that are described by statements appropriate to that dimension) will first be translated into utility measures. These measures are obtained at discrete time points, so they will be interpolated into the time intervals between the visits. Accordingly, we will use the inverse-probability weighted method of Zhao and Tsiatis to carry out the survival time analysis. | 20 months |
| Dallas |
| Texas |
| 75390 |
| United States |
| Md Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Baylor Research Institute Dallas, Baylor Irving | Irving | Texas | 75061 | United States |
| Texas Oncology - Sherman | Sherman | Texas | 75090 | United States |
| Scott & White Memorial Temple | Temple | Texas | 76508 | United States |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | United States |
Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation Therapy | Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks |
| BG001 | Conventional Radiation | Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Region of Enrollment | Number | number of participants |
| |||||||||||||||||||
| Baseline performance status | Zubrod Performance Scale will be used: 0 Fully active, able to carry on all predisease activities without restriction;
| 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 | Overall Survival of Standard Radiation (CFRT) Versus Accelerated, Hypofractionated, Image-guided Conformal Radiotherapy (IGRT) in Treatment of Stage II-III NSCLC in Patients With Poor Performance Status at 1 Year. | Percentage of participants with overall survival at 1 year. To compare the efficacy by overall survival of standard radiation versus accelerated, hypofractionated, image-guided conformal radiotherapy in treatment of stage II-III or recurrent NSCLC in patients with poor performance status. Overall survival time will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in survival distributions. The Cox proportional hazard regression model will be used to determine hazard ratios and 95% confidence intervals for the treatment difference in overall survival. Unadjusted ratios and ratios adjusted for stratification variables and other covariates of interest will be computed. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Toxicities of Two Radiotherapy Treatment Regimens in Patients With Stage II-III Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status | To compare toxicity of two radiotherapy treatment regimens in patient with stage II-III Non-Small Cell Lung Cancer (NSCLC) and poor performance status. Toxicity will be assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. | Posted | Number | events | 60 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Time to Local Progression of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status | The time to disease progression and time to local regression will be estimated using the Kaplan-Meier approach. The stratified log-rank test will be used to test for a statistically significant difference in PFS (progression-free survival) and time to local progression distributions. The Cox proportional hazard regression model will be used to determine hazard ratios and 95% confidence intervals for the treatment difference in progression-free survival and time to local progression. Time to progression will be measured from the date of study enrollment to the date of documented local progression as determined by clinical exam and imaging studies. | Posted | Median | 95% Confidence Interval | months | 60 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | Percentage of patients with disease-free survival at 60 months. To compare disease-free survival of two radiotherapy treatment regimens in patients with stage II-III NSCLC and poor performance status. Unlike progression-free survival in the advanced cancer setting, which refers to time from treatment to disease progression (or death) in patients who already have measurable cancer in their bodies, DFS (disease-free survival) refers to time from treatment until the recurrence of disease (or death) after undergoing curative-intent treatment. | Posted | Number | percentage of participants | 60 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | Patient-reported functional status will be assessed with the lung cancer subscales of the Functional Assessment of Cancer Therapy-Lung (FACT-L). The FACT-L is a 36-item questionnaire that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). | Data was not collected due to patient compliance. | Posted | 6 months |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Cost Effectiveness of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | For the primary analysis, we will estimate cost accumulated within 2 years. An inverse-probability weighting method to calculate average costs for each treatment group will be used to analyze. | Due to patient compliance with questionnaire completion, only 23 patients from Arm A and 29 patients from Arm B were analyzed. Sample size was too small for meaningful cost comparison. | Posted | Mean | 95% Confidence Interval | Cost of Treatment (in USD) | 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | The quality-adjusted survival time is just an integration of the utility measures over a patient's survival time, or until the time limit similar as the cost calculation, whichever occurs earlier. To estimate quality adjusted survival time, data from EQ-5D (EuroQol- 5 Dimension a descriptive system for health-related quality of life states in adults), each of which has five severity levels that are described by statements appropriate to that dimension) will first be translated into utility measures. These measures are obtained at discrete time points, so they will be interpolated into the time intervals between the visits. Accordingly, we will use the inverse-probability weighted method of Zhao and Tsiatis to carry out the survival time analysis. | Posted | Mean | 95% Confidence Interval | days | 20 months |
| |||||||||||||||||||||||||||||||
| Secondary | Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. | The quality-adjusted survival time is just an integration of the utility measures over a patient's survival time, or until the time limit similar as the cost calculation, whichever occurs earlier. To estimate quality adjusted survival time, data from the VAS (visual analogue scale: the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine') of EQ-5D (EuroQol- 5 Dimension a descriptive system for health-related quality of life states in adults), each of which has five severity levels that are described by statements appropriate to that dimension) will first be translated into utility measures. These measures are obtained at discrete time points, so they will be interpolated into the time intervals between the visits. Accordingly, we will use the inverse-probability weighted method of Zhao and Tsiatis to carry out the survival time analysis. | Posted | Mean | 95% Confidence Interval | adjusted days of follow up | 20 months |
|
60 months
Adverse events will be graded by a numerical score according to the defined NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe or medically significant but not immediately life threatening; Grade 4: Life threatening consequences; Grade 5: Death related to the 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 | Radiation Therapy | Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks Radiation Therapy: Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks | 32 | 50 | 0 | 50 | 28 | 50 |
| EG001 | Conventional Radiation | Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks Conventional radiation: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks | 26 | 46 | 0 | 46 | 23 | 46 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial Effusion | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| SVC (Superior vena cava) Syndrome | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Fatigue | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Chest Wall Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| ARDS (Acute respiratory distress syndrome) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| DLCO (Diffusion capacity of carbon monoxide) decline | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| FEV (forced expiratory volume) decline | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Dryness | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
Our study has several limitations. First, it was closed to accrual before the enrollment goal was attained due to futility in reaching the primary endpoint; consequently, the lower than anticipated number of participants limited our multivariate analysis. Second, more than half of the patients were from a single site (University of Texas Southwestern). Finally, the outcomes may have differed in an immuno-therapy setting.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Puneeth Iyengar | University of Texas Southwestern Medical Center | 214-645-7603 | puneeth.iyengar@utsouthwestern.edu |
| Mar 28, 2022 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Title | Measurements |
|---|---|
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| Ages 70-79 years |
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| Ages 80-90 years |
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| Male |
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| Black |
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| Asian |
|
| 1 |
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| 2 |
|
| 3 |
|
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| Counts |
|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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