Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to evaluate patient-reported outcomes during and after concurrent chemoradiotherapy for locally-advanced non-small cell lung cancer. Patients will be randomized to a standard 6-week radiotherapy course or a 4-week radiotherapy course using dose-painting based on pre-treatment Positron Emission Tomography (PET) findings.
This study is open for patients with non-small cell lung cancer. This study offers such patients the chance for a shorter and more personalized treatment course utilizing PET imaging.
Patients will be stratified based on performance status and tumor size and randomized to one of two treatment plans:
All patients will receive standard weekly doses of chemotherapy (carboplatin and paclitaxel) during radiotherapy. This may be followed by adjuvant systemic therapy, at the discretion of the treating physicians.
All patients will undergo standard evaluations prior to enrollment, during treatment, and after treatment. Additionally, patient-reported outcomes will be assessed periodically using a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard chemoradiotherapy | Active Comparator | Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes). |
|
| PET-based, dose-painted, accelerated chemoradiotherapy, | Experimental | For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with Metabolic Tumor Volume (MTV) exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-based, dose-painted, accelerated chemoradiotherapy | Combination Product | Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 | Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type. | Up to 6 Weeks after initiation of Chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Locoregional Progression-free Survival | Locoregional progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of local or regional disease progression or death, whichever comes first, censored at the date of data collection | Weeks 19, 32, and 45 on study |
Not provided
Inclusion Criteria:
Pathologically proven (either histologic or cytologic) diagnosis of NSCLC with any of the following stages according to the American Joint Committee on Cancer (AJCC) Staging Manual, 7th edition,
Appendix):
Appropriate diagnostic/staging workup, including:
All patients must sign study specific informed consent prior to study entry.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nitin Ohri, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
55 patients were consented into the study. 5 patients failed to meet inclusion criteria and were excluded from the study. 50 patients were enrolled and randomized into one of the two study arms.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Chemoradiotherapy (Control Arm) | Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes). Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | Nov 22, 2019 |
Not provided
Not provided
Study participants were stratified by performance status (2 vs 0-1) and primary tumor size (> 4cm or <= 4cm) and then randomized 1:1 to receive either PET-based, dose-painted radiotherapy or standard radiotherapy.
Not provided
Not provided
Not provided
Not provided
| Standard chemoradiotherapy | Combination Product | Patients in this arm will receive a standard radiotherapy course. |
|
| Progression-free Survival (PFS) |
Progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of disease progression or death, whichever comes first, censored at the date of data collection. PFS will be summarized by study arm using basic descriptive statistics. |
| Weeks 19, 32 and 45 on study |
| Overall Survival (OS) | Follow ups will be maintained with study patients to determine survival status. OS will be assessed during the interval from study registration to death, censored at the date of data collection. | Up to 45 weeks |
| Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0 | Evaluation of any Grade 3-5 adverse events, including Grade 3-5 side effects and toxicities, were assessed based on CTCAE Version 4.0. Adverse events/side effects/toxicities have been summarized by study arm. The number/percentage of patients with Grade 3-5 adverse events, scored using CTCAE Version 4.0, is summarized by study arm. | From treatment start through study week 45 |
| Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time | Evaluation of severe, patient reported side effects or toxicities was assessed. The number/percentage of patients with PRO-CTCAE, scored using CTCAE Version 4.0, is summarized by study arm. | From treatment start through study week 45 |
| Number of Patients With PRO-CTCAE Adverse Events With Any Score | Evaluation of any patient reported side effects or toxicities. This Outcome Measure includes PRO-CTCAE AEs that were Grades 0, 1, or 2. The number of patients with Grade 3 PRO-CTCAE have been summarized in the corresponding Outcome Measure. | From treatment start through study week 45 |
| PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm) |
For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks. PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Chemoradiotherapy (Control Arm) | Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes). Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course. |
| BG001 | PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm) | For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks. PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging. |
| 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 | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Clinical Stage | FDG-PET/CT imaging was conducted as part of staging workup for patients with NSCLC. Staging was classified as either Stage II, IIIA, IIIB, IIIC, or Stage IV based on the AJCC 7th Edition Staging Manual based on the TNM (Tumor, Node, Module) system to properly stage NSCLC. This system considers tumor size and local spread, involvement of nearby lymph nodes, and spread to distant sites. Patients with pathologically proven diagnosis of each Stage are summarized by study arm. Stages represent increasingly advanced stages of cancer, with higher numbers indicating greater spread and/or tumor size. | Count of Participants | Participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | ECOG PS describes patients level of functioning in terms of ability to care for themselves, daily activity, and physical ability, and is based on a 5 point scale (1-5) with higher scores indicative of increasing levels of disability. For this study, patients with ECOG PS scores of 0-2 were eligible (0 = no symptoms, normal activity level; 1 = symptomatic, but able to carry out daily activities; 2 = symptomatic, in bed < half of the day, needs some assistance with daily activities). ECOG PS scores were summarized by study arm. | Count of Participants | Participants |
| |||||||||||||||
| Histology, Carcinoma Subtype | Participant characteristics at baseline included the subtype of carcinoma patients randomized into the study were identified to have at diagnosis: adenocarcinoma (originating in an organ or gland) or squamous cell carcinoma (originating in the squamous epithelium). Carcinoma subtypes were summarized by study arm. | Count of Participants | Participants |
| |||||||||||||||
| Programmed Cell Death Ligand-1 Protein Expression | Protein expression at baseline was determined using the Programmed Cell Death Ligand-1 (PD-L1) Tumor Proportion Score (TPS). The PD-L1 test measures the percentage of cells in a tumor (viable cells) that express PD-L1. Specimens are considered to have 'high' PD-L1 expression if TPS score is ≥ 50%. For this study, the number of patients with TPS scores < 50% and ≥ 50% is summarized. | Count of Participants | Participants |
| |||||||||||||||
| Metabolic Tumor Volume (MTV) | Metabolic Tumor Volume (MTV) was calculated for each pulmonary tumor and involved lymph node at baseline using staging fluorodeoxyglucose positron emission tomography (FDG PET) images. For this study, a semiautomatic gradient-based contouring algorithm was used to contour each hypermetabolic lung tumor and regional lymph node. MTV refers to the metabolically active volume of the tumor segmented using FDG PET, and is useful in predicting outcome and assessing treatment response for radiotherapy treatment planning. MTV was summarized by study arm using basic descriptive statistics. | Median | Inter-Quartile Range | cubic centimeters |
| ||||||||||||||
| Adjuvant Systemic Therapy | The number of patients who were administered adjuvant systemic therapy during the study is summarized by study arm by the type of therapy administered. Adjuvant systemic therapy was permitted in both arms, at the discretion of the treating physicians. | 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 | Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 | Observation of Grade 3 or higher patient-reported toxicity six weeks after chemotherapy radiation was characterized utilizing the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a patient-reported outcome assessment tool developed by the National Cancer Institute (NCI) to capture symptomatic adverse events in patients on cancer clinical trials. Participants completed a customized PRO-CTCAE survey with 24 questions addressing 12 symptoms at baseline, every two weeks during chemoradiotherapy. The number of patients with PRO-CTCAE Grade 3 or higher adverse events was summarized by study arm for each event type. | 9 patients did not report PRO-CTCAE data at 6 weeks post chemoradiotherapy, 4 in the PET-based, dose-painted arm and 5 in the Standard Chemoradiotherapy (Control Arm). There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study. | Posted | Number | participants | Up to 6 Weeks after initiation of Chemoradiotherapy |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Locoregional Progression-free Survival | Locoregional progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of local or regional disease progression or death, whichever comes first, censored at the date of data collection | Posted | Number | percentage of participants | Weeks 19, 32, and 45 on study |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) | Progression-free survival will be evaluated based on repeat imaging and assessed during the interval from study registration to date of disease progression or death, whichever comes first, censored at the date of data collection. PFS will be summarized by study arm using basic descriptive statistics. | Posted | Number | percentage of participants | Weeks 19, 32 and 45 on study |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Follow ups will be maintained with study patients to determine survival status. OS will be assessed during the interval from study registration to death, censored at the date of data collection. | Posted | Number | percentage of participants | Up to 45 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3-5 Adverse Events, Scored Using CTCAE Version 4.0 | Evaluation of any Grade 3-5 adverse events, including Grade 3-5 side effects and toxicities, were assessed based on CTCAE Version 4.0. Adverse events/side effects/toxicities have been summarized by study arm. The number/percentage of patients with Grade 3-5 adverse events, scored using CTCAE Version 4.0, is summarized by study arm. | All events identified below were Grade 3 | Posted | Count of Participants | Participants | From treatment start through study week 45 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With PRO-CTCAE Adverse Events With Score ≥ 3 at Any Time | Evaluation of severe, patient reported side effects or toxicities was assessed. The number/percentage of patients with PRO-CTCAE, scored using CTCAE Version 4.0, is summarized by study arm. | There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study. | Posted | Count of Participants | Participants | From treatment start through study week 45 |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With PRO-CTCAE Adverse Events With Any Score | Evaluation of any patient reported side effects or toxicities. This Outcome Measure includes PRO-CTCAE AEs that were Grades 0, 1, or 2. The number of patients with Grade 3 PRO-CTCAE have been summarized in the corresponding Outcome Measure. | There were no Grade 4 or Grade 5 PRO-CTCAE adverse events during the course of the study. | Posted | Count of Participants | Participants | From treatment start through study week 45 |
|
Up to 5 years following treatment.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Chemoradiotherapy (Control Arm) | Patients receiving standard radiotherapy will receive a total dose of 60 Gy in 30 fractions over 6 weeks, delivered to all involved lesions (tumors and lymph nodes). Standard chemoradiotherapy: Patients in this arm will receive a standard radiotherapy course. | 15 | 27 | 4 | 27 | 27 | 27 |
| EG001 | PET-based, Dose-painted, Accelerated Chemoradiotherapy (Dose-Painting Arm) | For patients receiving PET-based, dose-painted, accelerated chemoradiotherapy, lesions with MTV exceeding 20 cc will be treated with 55 Gy in 20 fractions over 4 weeks, while lesions with MTV below 20 cc will receive 44 Gy in 20 fractions over the same 4 weeks. PET-based, dose-painted, accelerated chemoradiotherapy: Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging. | 12 | 23 | 6 | 23 | 23 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chest Pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase (ALT) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase (AST) increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Atrial Flutter/Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chronic Kidney Disease | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Difficulty elevating arm | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Eosinophilia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim Term: Esophageal stricture |
|
| Esophagitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | 2 patients in dose-painting arm had mucositis secondary to esophagitis, 1 patient in the dose-painting arm had throat burning secondary to esophagitis and 1 patient in the dose-painting arm had throat tightness secondary to esophagitis. |
|
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastroesophageal reflux disease (GERD) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Glucose intolerance | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hand tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cholesterol high | Investigations | CTCAE (4.0) | Systematic Assessment | Verbatim term: Hypercholesterolemia |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Verbatim Term |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Orthostatic hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Perianal growth | General disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Peripheral edema | General disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Peripheral neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Right Upper Lobe Opacity | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Restricted mobility | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Sleep impairment | General disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term |
|
| Dysgeusia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term: Taste changes |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Voice alterations | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment | Verbatim term: voice changes |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| White blood cell (WBC) decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Key limitations of this study include its modest sample size and the fact that it was conducted at a single institution. Although most local disease recurrences tend to occur in the first few years after chemoradiotherapy, longer follow-up will be helpful to ensure that disease control rates using our experimental regimen are acceptable.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nitin Ohri | Albert Einstein College of Medicine | 718-405-8550 | nitin.ohri@einsteinmed.edu |
| Jun 27, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2022 | Apr 3, 2025 | ICF_001.pdf |
Not provided
| 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 |
Not provided
Not provided
|
|
|
|
| Stage IIIA |
|
|
| Stage IIIB |
|
|
| Stage IIIC |
|
|
| Stage IV |
|
|
|
| 1 |
|
|
| 2 |
|
|
|
| Squamous Cell Carcinoma |
|
|
| Other/Not Specified |
|
|
|
| ≥ 50% |
|
|
| Unknown |
|
|
|
|
| Osimertinib |
|
|
| None |
|
|
| Nausea |
|
| Dyspnea |
|
| Cough |
|
| Wheezing |
|
| Dermatitis |
|
| Dizziness |
|
| Fatigue |
|
| Anxiety |
|
| Anhedonia |
|
| Depression |
|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|