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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-02481 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 16-008343 | Other Identifier | Mayo Clinic Institutional Review Board |
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This randomized phase II trial studies how well platinum doublet chemotherapy and proton beam radiation therapy work in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as carboplatin, paclitaxel, etoposide, cisplatin, and pemetrexed work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. Giving platinum doublet chemotherapy and proton beam radiation therapy may work better in treating patients with non-small cell lung cancer.
PRIMARY OBJECTIVE:
I. To compare the 1-year progression-free survival rates of 72 gray (Gy) and 60 Gy conventionally fractionated proton beam therapy (PBT) (as part of concurrent combined modality therapy).
SECONDARY OBJECTIVE:
I. To assess the adverse events, survival, quality of life, and patterns of failure (local regional, distant metastatic) associated with two dose levels of conventionally fractionated PBT (as part of concurrent combined modality therapy).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.
ARM C: Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.
All patients undergo computed tomography (CT) throughout the study, magnetic resonance imaging (MRI) or CT, and positron emission tomography (PET)/CT during screening.
After completion of study treatment, patients are followed up every 3 months for 3 years and then every 6 months for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (platinum doublet chemotherapy, lower dose PBT) | Experimental | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity. |
|
| Arm C (platinum doublet chemotherapy, higher dose PBT) | Experimental | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Progression Free Survival (PFS) | A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value < 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value < 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated | From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Will be modeled using Cox models. Kaplan-Meier estimates and curves by dose level will also be generated. OS will again be analyzed as exploratory analysis after 50 deaths per primary pairwise comparison have occurred or after all patients have completed follow-up (whichever occurs first). | From randomization to death due to any cause, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Post Treatment | Measured using the single item Linear Analogue Self-Assessment scale. Descriptive statistics by dose level at each time point will include means, standard deviations, medians, and ranges for each scale. Descriptive graphical techniques will include mean plots by dose over time for each scale. Mixed models will be used to compare each scale across dose levels at each post-baseline time point while adjusting for the baseline value of scale. Will graphically explore patterns of missing data and will employ pattern mixture models for longitudinal analyses. The lowest number measuring worst and higher number measuring best outcome. |
Inclusion Criteria:
Age >= 18 years
Histological confirmation of non-small cell lung cancer
Forced expiratory volume in 1 second (FEV1) > 1.0 L
Unresectable or medically inoperable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography [CT/PET], magnetic resonance imaging [MRI] or CT of brain, and physical exam);
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
White blood cell (WBC) >= 3.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Hemoglobin (Hgb) >= 9 g/dl
Platelets (plts) > 100 x 10^9/L
Serum creatinine < 1.5 x upper limits of normal (ULN)
Serum bilirubin < 1.5 x ULN
Provide informed written consent
Willing to return to enrolling institution for follow-up for a minimum of 1 year
Ability to undergo potentially curative chemotherapy plus radiotherapy
Exclusion Criteria:
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Weight loss of > 10% in the past 3 months
Distant metastases (M1 disease)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, lupus, usual interstitial pneumonitis (UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
Active second malignancy
History of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
Received chemotherapy for lung cancer within 6 months of registration
Previous chest radiotherapy that would overlap with the proton field
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| Name | Affiliation | Role |
|---|---|---|
| Terence T. Sio, M.D., M.S. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT) | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.> > Carboplatin: Chemotherapy> > Cisplatin: Chemotherapy> > Etoposide: Chemotherapy> > Paclitaxel: Chemotherapy> > Pemetrexed: Chemotherapy> > Proton Beam Radiation Therapy: Undergo PBT> > Quality-of-Life Assessment: Ancillary studies> > Questionnaire Administration: Ancillary studies |
| 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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2019 |
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| Cisplatin | Drug | Chemotherapy |
|
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| Etoposide | Drug | Chemotherapy |
|
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| Paclitaxel | Drug | Chemotherapy |
|
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| Pemetrexed | Drug | Chemotherapy |
|
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| Proton Beam Radiation Therapy | Radiation | Undergo PBT |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Number of Participants With Adverse Events | Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are graded on a scale of 0-5 with 5 being worst. The number of participants with Grade 2 or higher adverse events will be reported. | Up to 5 years |
| Proportion of Participants With Local-regional Failure | Defined as the proportion of participants with documentation of local recurrence. The cumulative incidence of local failure will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk). | Up to 5 years |
| Proportion of Participants With Distant Metastasis | Defined as the proportion of participants with documentation of distant metastasis. The cumulative incidence of distant metastasis will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk). | Up to 5 years |
| Up to 5 years |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| FG001 | Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT) | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.> > Carboplatin: Chemotherapy> > Paclitaxel: Chemotherapy> > Proton Beam Radiation Therapy: Undergo PBT> > Quality-of-Life Assessment: Ancillary studies> > Questionnaire Administration: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT) | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo lower dose proton beam radiation therapy daily for a total of 60 Gy for up to 30 weekdays in the absence of disease progression or unacceptable toxicity.> > Carboplatin: Chemotherapy> > Cisplatin: Chemotherapy> > Etoposide: Chemotherapy> > Paclitaxel: Chemotherapy> > Pemetrexed: Chemotherapy> > Proton Beam Radiation Therapy: Undergo PBT> > Quality-of-Life Assessment: Ancillary studies> > Questionnaire Administration: Ancillary studies |
| BG001 | Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT) | Patients receive platinum based doublet chemotherapy consisting of low dose carboplatin and paclitaxel, standard etoposide cisplatin or carboplatin or standard pemetrexed with cisplatin or carboplatin weekly for up to 6 weeks at the discretion of the treating medical oncologist. Patients also undergo higher dose proton beam radiation therapy daily for a total of 72 Gy for up to 36 weekdays in the absence of disease progression or unacceptable toxicity.> > Carboplatin: Chemotherapy> > Paclitaxel: Chemotherapy> > Proton Beam Radiation Therapy: Undergo PBT> > Quality-of-Life Assessment: Ancillary studies> > Questionnaire Administration: Ancillary studies |
| 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, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Method of Payment | Count of Participants | Participants |
| ||||||||||||||||
| Height (Cm) | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight (Kg) | Mean | Standard Deviation | Kg |
| |||||||||||||||
| Smoking Cessation | Count of Participants | Participants |
| ||||||||||||||||
| Baseline QOL | QOL score that can be collected in a minute or so by having each patient judge the overall quality of their lives with a single 0-100 scale. Higher is better. | Count of Participants | Participants |
| |||||||||||||||
| ECOG Performance Status | 0: Fully active, able to carry on all pre-disease performance without restriction 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 0 is better than 1 | One patient on Arm C is missing ECOG data | Count of Participants | Participants |
| ||||||||||||||
| Mayo prognostic score | The score for each prognostic factor totaled up to a score into a category of of 32-37, 38-43, 44-47, 48-52. Lower is better | 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 | Proportion of Participants With Progression Free Survival (PFS) | A Cox proportional hazards model stratified by stratification factors will be used to model PFS as a function of dose to test for an overall dose effect (a one-sided p-value < 0.10 will be considered as significant evidence of a dose effect). Subsequently, separate Cox models stratified by stratification factors will compare PFS between 72 Gy and 60 Gy (for each, a one-sided p-value < 0.10 will be considered as significant evidence of superiority). Kaplan Meier estimates and curves by dose level will also be generated | Posted | Number | 95% Confidence Interval | proportion of participants | From randomization to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Will be modeled using Cox models. Kaplan-Meier estimates and curves by dose level will also be generated. OS will again be analyzed as exploratory analysis after 50 deaths per primary pairwise comparison have occurred or after all patients have completed follow-up (whichever occurs first). | Posted | Count of Participants | Participants | From randomization to death due to any cause, assessed up to 5 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Adverse events are graded on a scale of 0-5 with 5 being worst. The number of participants with Grade 2 or higher adverse events will be reported. | Posted | Count of Participants | Participants | Up to 5 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Local-regional Failure | Defined as the proportion of participants with documentation of local recurrence. The cumulative incidence of local failure will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk). | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 5 years |
| |||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Distant Metastasis | Defined as the proportion of participants with documentation of distant metastasis. The cumulative incidence of distant metastasis will be estimated using Gray's methodology and compared across dose levels using Fine-Gray quadratic regression (with death as a competing risk). | Posted | Number | 95% Confidence Interval | proportion of participants | Up to 5 years |
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Quality of Life Post Treatment | Measured using the single item Linear Analogue Self-Assessment scale. Descriptive statistics by dose level at each time point will include means, standard deviations, medians, and ranges for each scale. Descriptive graphical techniques will include mean plots by dose over time for each scale. Mixed models will be used to compare each scale across dose levels at each post-baseline time point while adjusting for the baseline value of scale. Will graphically explore patterns of missing data and will employ pattern mixture models for longitudinal analyses. The lowest number measuring worst and higher number measuring best outcome. | Not Posted | Up to 5 years | Participants |
Up to 5 years
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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 | Arm A (Platinum Doublet Chemotherapy, Lower Dose PBT) | Questionnaire Administration: Ancillary studies | 6 | 10 | 5 | 10 | 10 | 10 |
| EG001 | Arm C (Platinum Doublet Chemotherapy, Higher Dose PBT) | Questionnaire Administration: Ancillary studies | 5 | 9 | 5 | 9 | 7 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | CTCAE 5 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Pain | General disorders | CTCAE 5 | Systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE 5 | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE 5 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE 5 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE 5 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven E. Schild | Mayo Clinic | 480-342-4800 | sschild@mayo.edu |
| Jun 18, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 1, 2023 | Sep 25, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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 |
|---|---|
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| D005047 | Etoposide |
| D017239 | Paclitaxel |
| D013660 | Taxes |
| D000068437 | Pemetrexed |
| D061766 | Proton Therapy |
| D011522 | Protons |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| 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 |
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D006859 | Hydrogen |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
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| MEDICARE AND PRIVATE INSURANCE |
|
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| PRIVATE INSURANCE |
|
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| Kept smoking |
|
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| Non-smoker |
|
|
|
| 70 |
|
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| 80 |
|
|
| 90 |
|
|
| 100 |
|
|
|
| 1 |
|
|
|
| 38-43 |
|
|
| 44-47 |
|
|
| 48-52 |
|
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|
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|
|
|
|
|
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