Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Image Guided Radiation Therapy

Intensity-Modulated Radiation Therapy

Laboratory Biomarker Analysis

Photon Beam Radiation Therapy

Proton Beam Radiation Therapy

Questionnaire Administration

Zhongxing Liao

This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.

PRIMARY OBJECTIVES:

I. To establish the maximum tolerated dose (MTD) of image-guided intensity-modulated photon (IMRT) and proton therapy (IMPT) both with simultaneous integrated boost (SIB) dose escalation to the SIBVi (internal SIB volume; defined as the gross tumor volume with consideration of respiratory motion plus setup uncertainty margin) for patients with stage II/IIIB non-small cell lung cancer (NSCLC) receiving concurrent standard chemotherapy and proton irradiation. (Phase I) II. Assess and compare survival free of grade III treatment related toxicity and local progression-free survival from day 1 of concurrent chemoradiation for stage II-IIIB NSCLC patients treated with image-guided robustly-optimized IMPT versus (vs.) IMRT, both delivered with simultaneous integrated boost (SIB). (Phase II)

SECONDARY OBJECTIVES:

I. Determine treatment-related acute and late toxicity. II. Correlate changes in standardized uptake values (SUV) on positron emission tomography (PET) and study endpoints (toxicity, tumor response, local control).

III. Correlate changes in peripheral blood biomarkers (genes, micro-ribonucleic acid \[RNA\], proteins) and the study endpoints.

IV. Estimate progression-free and overall survival. V. Document and compare symptom burden before starting chemoradiation, weekly during treatment, bi-weekly from end of treatment until first follow up, and at each follow-up visit thereafter by using the MD Anderson Symptom Inventory - Plus (MDASI-Plus) and European Quality of Life Instrument-5 dimensions (EQ-5D).

VI. Perform cost effectiveness between IMPT and IMRT both with SIB treatment. VII. Correlate imaged response, clinical response, blood biomarkers and symptom burdens to dose distribution patterns.

OUTLINE: This is a phase I, dose-escalation study followed by a randomized phase II study.

PHASE I: Patients undergo image-guided IMRT with SIB or IMPT with SIB once daily (QD) 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

PHASE II: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)

Will be defined as the highest simultaneous integrated boost volume (SIBV) dose that has posterior probability of dose-limiting toxicity (DLT) =\< 30%. DLT are defined as Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

Will be defined as the highest SIBV dose that has posterior probability of DLT =\< 30%. DLT are defined as CTCAE 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

Will be defined as tumor recurrence or progression inside or at the boundary of the volume defined by the 60 Gy (relative biological effectiveness) isodose line. A Bayesian method will be applied.

The product-limit estimator of Kaplan and Meier will be used.

A 90% credible interval will be reported for this rate. Toxicities will be tabulated by severity and relationship to radiation therapy.

Correlate changes in peripheral blood biomarkers (genes, ctDNA, microRNA, exosomes, proteins) and the study endpoints. Cox proportional hazards regression will be used to estimate the relationship between changes in selected biomarkers and time to local failure, progression-free survival, and overall survival.

Descriptive statistics and box plots will be used and will be measured by participants answers to the survey.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Rare Diseases

Glioblastoma

Gliosarcoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Lomustine

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Quality-of-Life Assessment

Site Public Contact

Erika Santos Horta

Richard M. Green

Samantha A. Seaward

Christopher U. Jones

Shahzad Siddique

Gigi Q. Chen

Xiao-Tang Kong

Rubens Chang

Karng S. Log

Robert Cavaliere

Zhijian Chen

Gerald C. Wallace

Vamsi K. Vasireddy

Thomas J. Saphner

Bryan A. Faller

Ahmad Daher

Jiayi Huang

Daniel W. Weed

Joseph J. Merchant

Deborah W. Wilbur

Richard L. Deming

Donald B. Wender

Tolga Tuncer

Fabio M Iwamoto

This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, 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 photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma.

PRIMARY OBJECTIVE:

I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) versus (vs.) standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma (GBM) with MGMT promoter methylation.

SECONDARY OBJECTIVES:

I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

II. To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation.

III. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in patient reported outcomes (PROs) as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation.

IV. To assess toxicity in the two different chemotherapy regimens.

EXPLORATORY OBJECTIVES:

I. To assess the association between absolute lymphocyte counts and outcomes. II. To assess the association between CD4+ lymphocyte counts and outcomes. III. To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo radiation therapy 5 days per week and receive temozolomide orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months thereafter.

Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma

A Phase III Trial of Gleostine® (Lomustine)-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients With Methylated MGMT Promoter Glioblastoma

Will assess the association between absolute lymphocyte counts and outcomes.

The Kaplan-Meier method will be used to estimate survival distribution for each treatment arm.

Analysis will consist of estimation of the PFS distribution of each treatment arm via the Kaplan-Meier method and a stratified log-rank test. Additional analyses may consist of estimating the hazard ratio (HR) via the Cox proportional hazards model, accounting for other prognostic covariates (and evaluating whether the proportional hazards assumption holds or whether any treatment effect is notably time-varying), and evaluating for potential treatment by prognostic covariate interactions.

Adverse events (AEs) will be graded according to Common Terminology Criteria for Adverse Events version 5.0. Comprehensive summaries of all AEs by treatment arm will be generated and examined.

Measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed glioblastoma with MGMT promoter methylation.

NRG Oncology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Oropharyngeal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Patients undergo IMRT QD five days a week for approximately 6.5 weeks.

Patients undergo IMPT QD five days a week for approximately 6.5 weeks.

Steven J Frank

This randomized phase II/III trial studies the side effects and how well intensity-modulated proton beam therapy works and compares it to intensity-modulated photon therapy in treating patients with stage III-IVB oropharyngeal cancer. Radiation therapy uses high-energy x-rays, protons, and other types of radiation to kill tumor cells and shrink tumors. It is not yet known whether intensity-modulated proton beam therapy is more effective than intensity-modulated photon therapy in treating oropharyngeal cancer.

PRIMARY OBJECTIVES:

I. To compare the rates and severity of late grade 3-5 toxicity between intensity-modulated photon therapy (IMRT) and intensity-modulated proton therapy (IMPT) following the treatment of oropharyngeal tumors. (Phase II) II. To compare the rate of 3-year progression-free survival (PFS) between concurrent chemo-radiation strategies with IMRT and IMPT following the treatment of oropharyngeal tumors. (Phase III)

SECONDARY OBJECTIVES:

I. Disease-related outcomes (2-year progression-free survival, patterns of failure, 2-year overall survival, 2-year \[yr\] distant metastasis free survival, and second primary cancers). (Phase III) II. Patient Reported Outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN), Xerostomia and Health Questionnaire (European Quality of Life 5-Dimension three level scale \[EQ-5D-3L\]), work status (Work Productivity and Activity Impairment: Specific Health Problem \[WPAI: SHP\]). (Phase III) III. Physician reported toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0. (Phase III) IV. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. (Phase III) V. Cost-benefit economic analysis of treatment. (Phase III) VI. To determine whether specific molecular profiles are associated with overall or progression-free survival. (Phase III) VII. To investigate associations between changes in serum biomarkers or human papillomavirus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. (Phase III) VIII. To bank peripheral blood at time of enrollment, weeks 2, 4, and 6 during treatment and during follow up visits for 2 years to explore the ability of circulating markers to predict outcome. (Phase III) IX. To bank head and neck tissues to explore the ability of tissue-based markers to predict outcome. (Phase III) X. To bank peripheral blood and tissues for future interrogations. (Phase III) XI. Acute side effects of radiation therapy will be assessed. (Phase III)

EXPLORATORY OBJECTIVE:

I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but were denied insurance coverage for the treatment arm she/he was randomized to; or may have dropped out of the study for other reasons after being randomized. These patients will compromise Group 3: consisting of patients randomized to Protons but not treated and Group 4: consisting of patients randomized to IMRT but not treated at the designated institution. Furthermore, these patients will only be followed for recurrence and survival.(Phase III)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo IMRT once daily (QD) five days a week for approximately 6.5 weeks.

ARM II: Patients undergo IMPT QD five days a week for approximately 6.5 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 5 years.

Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer

Phase II/III Randomized Trial of Intensity-Modulated Proton Beam Therapy (IMPT) Versus Intensity-Modulated Photon Therapy (IMRT) for the Treatment of Oropharyngeal Cancer of the Head and Neck

Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., human papillomavirus (HPV)/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.

Will be graded according to the NCI CTCAE version 4.0. The methods described by Gooley will be used to estimate the cumulative incidence of late onset grade 3+ toxicity by 2 years for each treatment arm with death as a competing risk. The methods of Fine and Gray will be used to model the cumulative incidence of late onset grade 3+ toxicity by 2 years as a function of treatment arm and other potential prognostic factors (e.g., HPV/p16 status, use of induction chemotherapy) considering death as a competing risk. Hazard ratios for the prognostic factors from this model with 95% confidence intervals will be estimated.

Stratified by treatment arm and estimated using the product limit estimator of Kaplan and Meier. Cox proportional hazards regression will be used to model OS as a function of potential prognostic factors. Hazard ratios for the prognostic factors from this model will be estimated with 95% confidence intervals.

Will be summarized at critical time points using the method of Kaplan-Meier. Kaplan-Meier plots will be used to visualize the time-to-event information by treatment arm, and the trial will be monitored based on results from log-rank tests used to compare treatment arms. Furthermore, Cox proportional hazards regression will be used to assess the time-to-event outcomes while adjusting for covariates of interest.

QoL assessments will be summarized using the mean score and standard deviation for each time point of interest. Mean response trajectories will be plotted over the time horizon for each QoL instrument administered to patients in order to explore differences between treatment arms along with other patient characteristics of interest. Other analyses such as area under the curve and linear mixed models will be used to make statistical comparisons between treatment arms while adjusting for covariates of interest.

National Institute of Dental and Craniofacial Research (NIDCR)

Dermatologic Agents

Micronutrients

Hematinics

Amino Acids

Vitamins

Etoposide

Antibodies

Paclitaxel

Carboplatin

Pemetrexed

Albumin-Bound Paclitaxel

Cisplatin

Durvalumab

Etoposide phosphate

Podophyllotoxin

Immunoglobulins

Immunoglobulin G

Immunoglobulins, Intravenous

Antibodies, Monoclonal

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Immunologic Factors

Keratolytic Agents

Glutamic Acid

Folinic Acid

Folate

Vitamin B9

Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* IV over 1 hour and carboplatin\* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancer may receive pemetrexed IV and carboplatin IV on every 21 days. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.

CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* and carboplatin\*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I. Patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.

CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

Pemetrexed Disodium

This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, 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. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. To compare the overall survival (OS) in patients with stage II-IIIB non-small cell lung cancer (NSCLC) after image guided, motion-managed photon radiotherapy (Arm 1) or after image guided, motion-managed proton radiotherapy (Arm 2) both given with concurrent platinum- based chemotherapy.

II. To compare the cardiac toxicity and lymphocyte reduction (lymphopenia) definitely, probably, or possibly related to treatment between the 2 arms.

SECONDARY OBJECTIVES:

I. To compare 2-year progression-free survival (PFS) between the 2 arms. II. To compare the development of grade 3 or higher adverse events not included above that are definitely, probably, or possibly related to treatment.

III. To compare differences between the two arms in quality of life (QOL) based primarily on the development of shortness of breath at 6 months and secondarily on the development of sore throat at the end of chemoradiotherapy (chemoRT) (as measured by the lung cancer module of the MD Anderson Symptom Inventory \[MDASI-Lung\]), as well as breathing related functioning impairments as measured by the Shortness Breath Questionnaire \[SOBQ\].

IV. To compare cost-effectiveness outcomes between the 2 arms. V. To compare pulmonary function changes by treatment arms and response. VI. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout radiation therapy processes, including imaging, simulation, patient immobilization, target and critical structure definition, treatment planning, image guidance and delivery.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* intravenously (IV) over 1 hour and carboplatin\* IV weekly during radiation therapy or etoposide IV on days 1-5 and 29-33 and cisplatin IV on days 1, 8, 29, and 36. Patients with non-squamous cell cancera may receive pemetrexed IV and carboplatin IV on every 21 days.

ARM II: Patients undergo proton beam radiation therapy 5 days per week for a total of 35 fractions and receive either paclitaxel\* and carboplatin\*, etoposide and cisplatin, or pemetrexed and carboplatin (for non-squamous cell cancer patients only) as in Arm I.

\*In both arms, patients who receive paclitaxel and carboplatin must complete 2 courses of consolidation therapy.

CONSOLIDATION THERAPY: Beginning 3-6 weeks after chemoradiotherapy, patients receive either paclitaxel IV over 3 hours and carboplatin IV on day 1 or durvalumab IV every 2 weeks. Treatment repeats every 21 days for 2 courses or every 2 weeks for up to 12 months for durvalumab in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell carcinoma may receive durvalumab or pemetrexed IV and carboplatin IV on day 1 every 21 days for up to 4 courses.

After completion of study treatment, patients are followed up at 4-8 weeks, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer

Phase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC

The time from study registration until death or last follow-up

The time from study registration until the first occurrence of local, regional, or distant progression, or death from any cause, or until last follow-up

Incidence of treatment-related grade 3-5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer	NCT01629498	Recurrent Lung ... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S... Stage IIIA Non-... Stage IIIB Lung...	Image Guided Ra... Image Guided Ra... Intensity-Modul... Intensity-Modul... Laboratory Biom... Photon Beam Rad... Proton Beam Rad... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer	NCT01629498	Recurrent Lung ... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S... Stage IIIA Non-... Stage IIIB Lung...	Image Guided Ra... Image Guided Ra... Intensity-Modul... Intensity-Modul... Laboratory Biom... Photon Beam Rad... Proton Beam Rad... Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma	NCT05095376	Glioblastoma Gliosarcoma	Lomustine Photon Beam Rad... Quality-of-Life... Questionnaire A... Temozolomide	18 Years - 70 Years	NRG Oncology
Intensity-Modulated Proton Beam Therapy or Intensity-Modulated Photon Therapy in Treating Patients With Stage III-IVB Oropharyngeal Cancer	NCT01893307	Stage III Oroph... Stage IVA Oroph... Stage IVB Oroph...	Intensity-Modul... Intensity-Modul... Laboratory Biom... Photon Beam Rad... Proton Beam Rad... Quality-of-Life...	18 Years -	M.D. Anderson Cancer Center
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer	NCT01993810	Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S... Stage III Non-S... Stage IIIA Non-... Stage IIIB Non-...	Carboplatin Cisplatin Durvalumab Etoposide Paclitaxel Pemetrexed Diso... Photon Beam Rad... Proton Beam Rad... Quality-of-Life... Questionnaire A...	18 Years -	Radiation Therapy Oncology Group

Spots Global Cancer Trial Database for photon beam radiation therapy