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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E2202 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cancer and Leukemia Group B | NETWORK |
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RATIONALE: Laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery.
PURPOSE: This phase II trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage I, stage II, or stage III esophageal cancer.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. Mortality at 30 days is assessed.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
ACTUAL ACCRUAL: A total of 110 patients were accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive esophagectomy (MIE) | Experimental | Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive esophagectomy (MIE) | Procedure | Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE. |
| Measure | Description | Time Frame |
|---|---|---|
| Peri-operative Mortality at 30 Days | The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported. | Assessed at 30 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Conversion to Open Operation | Proportion of patients who required conversion to operation will be reported. | Assessed at surgery |
| Duration of Operating Time | The length of the operation (total of thoracic and abdominal components) is recorded. |
Not provided
INCLUSION CRITERIA:
DISEASE CHARACTERISTICS:
High grade dysplasia of the esophagus who would undergo esophagectomy OR esophageal cancer at stage T1-T3, N0-N1 who require esophagectomy (patients with M1 disease and/or bulky lymph node involvement were excluded).
Pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy.
Computerized tomography (CT) scan of chest and abdomen within 6 weeks prior to registration
Stomach must be available for conduit
Age of 18 and over
ECOG performance status of 0-2
Creatinine less than 2 mg/dL
Patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. If patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed.
The patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. Pre-operative staging should include:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| James D. Luketich, MD | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange | California | 92868 | United States | ||
Not provided
This study was activated on March 3, 2004, accrued its first patient on June 24, 2004, and closed on August 15, 2008. A total of 110 patients were accrued for this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Minimally Invasive Esophagectomy (MIE) | Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE. Only eligible and treated patients are included in the primary analysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Assessed at surgery |
| Duration of Intensive Care Stay | Number of post-operative days in intensive care is reported. | Assessed after surgery until patients are out of intensive care |
| Overall Length of Hospital Stay | The number of days patients stayed in the hospital after surgery is reported. | Assessed after surgery until patients are out of hospital |
| Total Number of Lymph Nodes Dissected | The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE. | Assessed at surgery |
| 3-year Survival Rate | Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death. | Assessed at 3 years |
| 30-day Peri-operative Mortality After Neoadjuvant Therapy | Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported. | Assessed at 30 days after surgery |
| Rate of Conversion to Open Operation After Neoadjuvant Therapy | Proportion of patients with neoadjuvant therapy required conversion to open operation is reported. | Assessed at surgery |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center |
| Savannah |
| Georgia |
| 31403-3089 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Meeker County Memorial Hospital | Litchfield | Minnesota | 55355 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | 68106 | United States |
| Immanuel Medical Center | Omaha | Nebraska | 68122 | United States |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | 68124 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131-2197 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | 17822-0001 | United States |
| UPMC Cancer Centers | Pittsburgh | Pennsylvania | 15232 | United States |
| Geisinger Medical Group - Scenery Park | State College | Pennsylvania | 16801 | United States |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | 18711 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Treated |
|
| Eligible and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Minimally Invasive Esophagectomy (MIE) | Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE. Only eligible and treated patients are included in the primary analysis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Peri-operative Mortality at 30 Days | The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported. | Eligible and treated patients are included in this analysis. | Posted | Number | 90% Confidence Interval | proportion of participants | Assessed at 30 days from surgery |
|
|
| |||||||||||||||||||||||||
| Secondary | Rate of Conversion to Open Operation | Proportion of patients who required conversion to operation will be reported. | Eligible and treated patients are included in this analysis. | Posted | Number | 95% Confidence Interval | Proportion of patients | Assessed at surgery |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Operating Time | The length of the operation (total of thoracic and abdominal components) is recorded. | Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients. | Posted | Median | Full Range | Minutes | Assessed at surgery |
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Intensive Care Stay | Number of post-operative days in intensive care is reported. | Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients. | Posted | Median | Full Range | Days | Assessed after surgery until patients are out of intensive care |
|
| ||||||||||||||||||||||||||
| Secondary | Overall Length of Hospital Stay | The number of days patients stayed in the hospital after surgery is reported. | Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients. | Posted | Median | Full Range | Days | Assessed after surgery until patients are out of hospital |
|
| ||||||||||||||||||||||||||
| Secondary | Total Number of Lymph Nodes Dissected | The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE. | Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients. | Posted | Median | Full Range | Lymph nodes | Assessed at surgery |
|
| ||||||||||||||||||||||||||
| Secondary | 3-year Survival Rate | Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death. | Eligible and treated patients are included in this analysis. | Posted | Number | 95% Confidence Interval | proportion of participants | Assessed at 3 years |
|
| ||||||||||||||||||||||||||
| Secondary | 30-day Peri-operative Mortality After Neoadjuvant Therapy | Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported. | 35 eligible and treated patients with neoadjuvant therapy are included in this analysis. | Posted | Number | 90% Confidence Interval | Proportion of patients | Assessed at 30 days after surgery |
|
| ||||||||||||||||||||||||||
| Secondary | Rate of Conversion to Open Operation After Neoadjuvant Therapy | Proportion of patients with neoadjuvant therapy required conversion to open operation is reported. | 35 eligible and treated patients with neoadjuvant therapy are included in this analysis. | Posted | Number | 95% Confidence Interval | Proportion of patients | Assessed at surgery |
|
|
Assessed during surgery and for 30 days after the end of treatment.
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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 | Minimally Invasive Esophagectomy (MIE) | Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE. Only eligible and treated patients are included in the primary analysis. | 75 | 105 | 74 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac-ischemia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac-other | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional, other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Wound - non-infectious | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Death NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death - multiorgan failure | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula, Colon/cecum/appendix | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula, Esophageal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leak (including anastomotic, esophagitis) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction, small bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction, stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stenosis (including anastomotic) esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hematoma | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Upper GI, hemorrhage NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Surgical hemorrhage | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g. C.diff) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, jejunum | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, mediastinm | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, neck NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, pleura | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, upper airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infectionw/ Gr0-2 neutropenia, wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC foreign body | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC peritoneal cavity | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC pleura (empyema) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ unknown ANC upper aerodigest | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Opportunistic infection lymphopenia>=grade 1 | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection w/ Gr0-2 neutropenia, blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Chyle or lymph leakage | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema trunk/genital | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| ALT increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST increased | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nonneuropathic generalized weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Laryngeal nerve dysfunction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdomen, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest wall, pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagus, pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleura, pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula trachea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction, airway-larynx | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prolong intubation post pulm resection | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Intra-op injury Spleen | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Intra-op injury Vein inferior vena cava | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular access,Thrombosis/embolism | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
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