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| ID | Type | Description | Link |
|---|---|---|---|
| STU00006779 | Other Identifier | Northwestern University IRB |
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RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed every 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction, Combination and surgery | Experimental | Weeks 1-6: Capecitabine 1000mg/m2 twice daily Oxaliplatin 70mg/m2 on days 1 and 8 Weeks 7-12: Capecitabine 825 mg/m2 twice daily Oxaliplatin 50mg/m2 weekly Radiation 1.8 Gy Monday-Friday Evaluation for response and resection surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction Therapy - Capecitabine | Drug | Two 21-day cycles will be given as induction. Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine Pathologic Complete Response | Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer | At time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate | Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) . Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
No distant metastatic disease (other than regional lymph nodes)
No evidence of CNS metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Mulcahy, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
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The study opened for accrual on May 31, 2006 with an accrual goal of up to 43 patients. The study was designed to enroll 13 patients initially and do an interim efficacy assessment. Accrual was suspended on July 17, 2008 for this analysis and reopened on August 12, 2008. The study was closed permanently on february 24, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction and Combination Treatment | Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6: Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle. Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12: Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle. Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy. 4-6 weeks later subjects will undergo evaluation for response and surgical resection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Treatment |
|
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| Induction Therapy - Oxaliplatin | Drug | Two 21-day cycles will be given as induction. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over two hours on days 1 and 8 of each cycle. |
|
| Combination Therapy - Capecitabine | Drug | Two 21-day cycles will be given for combination therapy. Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks. |
|
| Combination Therapy - Oxaliplatin | Drug | Two 21-day cycles will be given. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle. |
|
| Combination Therapy - Radiation | Radiation | 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy. |
|
| Evaluation for response and surgery | Procedure | Four to eight weeks following the completion of therapy subjects will undergo evaluation for response and surgical resection. |
|
| four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery |
| Recurrence Rate | Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study. | From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months. |
| Time to Progression | Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact. | From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months. |
| Patterns of Failure | At time of surgery |
| Toxicity Profile | Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0) In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Only incidents of AEs determined to be related to chemotherapy are recorded here. | During chemotherapy treatment and up to 30 days post-last dose of chemotherapy. |
| Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy. | At time of sugery |
| Registered to Study |
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| Started Induction Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| Evaluated for Combination Treatment |
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| Combination Treatment |
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| Evaluation for Response and Surgery |
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| Survival Follow up Until Death |
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Patients that completed induction of capecitabine and oxaliplatin, were then enrolled and completed treatment in capecitabine, oxaliplatin, and radiation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Induction and Combination Treatment | Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6: Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle. Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12: Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle. Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy. 4-6 weeks later subjects will undergo evaluation for response and surgical resection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
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| 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 | Determine Pathologic Complete Response | Pathologic response will be assessed semiquantitatively irrespective of lymph node status based on the estimated percentage of residual carcinoma in relation total carcinoma area, including amount of radiotherapy-induced tissue injury, in mural histologic sections. Pathologic response will be defined as: P0: 0% residual cancer P1: 1% to 50% residual cancer P2: more than 50% residual cancer | Patients analyzed were patients that reached and completed surgery. | Posted | Count of Participants | Participants | At time of surgery |
|
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| ||||||||||||||||||||||||||
| Secondary | Clinical Response Rate | Clinical response Rate will be expressed as the proportion of patients demonstrating a complete and/or partial response based on all evaluable patients treated.Clinical response will be evaluated according to Response Evaluation Criteria In Solid Tumors 1.0 (RECIST) . Complete Response (CR) is defined as the disappearance of all target lesions Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,taking as reference the baseline sum LD | 1 patient was registered to the study but was not treated on study and was therefore not evaluable. | Posted | Count of Participants | Participants | four to six weeks following completion of 4 cycles (1 cycle = 21days) of chemotherapy treatment and prior to surgery |
| ||||||||||||||||||||||||||||
| Secondary | Recurrence Rate | Recurrence rate will be defined as disease recurrence, progressive disease or death. Patients will be followed for disease recurrence or death until the end of the study. | 1 patient was registered but not treated on study and therefore was not evaluable. | Posted | Count of Participants | Participants | From the time of start of treatment until first documentation of disease recurrence, progression or death, whichever comes first until the end of the study, a maximum of 6 years and 7 months. |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Progression | Time to Progression will be measured as time from the first day of therapy until death, disease progression or last contact. | Data collected was not analyzed before the study was terminated. Count of participants indicates the number of patients with progressive disease or death at the time the study closed permanently. | Posted | Count of Participants | Participants | From start of first treatment until time of first documentation of progression of disease or death, whichever comes first, until the study closes, up to a maximum of 6 years and 7 months. |
| ||||||||||||||||||||||||||||
| Secondary | Patterns of Failure | No data collected for this outcome measure. There is no data to report on. | Posted | At time of surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Toxicity Profile | Toxicity will be assessed at the beginning of every cycle during chemotherapy for a total of 4 cycles (1 cycle =21 days) and then 30 days post last dose of chemotherapy. All toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE 3.0) In general adverse events (AEs) will be graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE Only incidents of AEs determined to be related to chemotherapy are recorded here. | Toxicity data was collected and analysed for the first 40 patients. | Posted | Number | participants | During chemotherapy treatment and up to 30 days post-last dose of chemotherapy. |
| ||||||||||||||||||||||||||||
| Secondary | Correlate Proteomic and Pharmacologic Characteristics With Prognosis and Response to Therapy. | No data was collected for this outcome measure. There is no data to report on. | Posted | At time of sugery |
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| ||||||||||||||||||||||||||||||
| Post-Hoc | Determine Progressive Free Survival | The only data collected for this outcome measure was progression free survival rate at 3 months, 6 months, and 12 months. | Posted | Number | percentage of patents progression free | After cycles 2, and 4 (pre-surgery) 30 days after surgery and then every 3 months until first documentation of progressive disease, death and up to a maximum of 24 months. |
|
| ||||||||||||||||||||||||||||
| Post-Hoc | Overall Survival | 1 patient was registered to the study, but was not treated on study and was therefore not evaluable. Data for overall surivival was collected at 3 months, 6 months, 12 months and 24 months. There was no further data analysis completed | Posted | Number | percentage of patients alive | From the start of treatment and then every 3 months until death or a maximum of 24 months. |
|
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Adverse events were collected over 6 years, 7 months.
For this study, only adverse events of the highest grade that were considered clinically significant were collected. Only serious adverse event that are fatal or life-threatening (i.e., results in an immediate risk of death), is permanently or substantially disabling, requires or prolongs hospitalization (only of related to an unexpected complication), or is a congenital anomaly, new cancer or medication overdose, or that the investigator deemed important were collected.
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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 | Induction and Combination Treatment | Induction Therapy: Two 21-day cycles will be given as induction. Weeks 1-6: Capecitabine will be given at 1000 mg/m2 twice daily approximately 12 hours apart for 14 days, followed by seven days off. Oxaliplatin will be given at 70 mg/m2 intravenously in 5% dextrose over 2 hours on days 1 and 8 of each cycle. Combination Therapy: Two 21-day cycles will be given for combination therapy Weeks 7-12: Capecitabine will be given at 825 mg/m2 twice daily approximately 12 hours apart for five days (Monday through Friday) followed by two days off for 51/2 weeks. Oxaliplatin will be given at 50 mg/m2 intravenously in 5% dextrose over two hours on days 1, 8 and 15 of each cycle. Radiation: 1.8 Gy daily Monday through Friday to a total of 50.4 Gy for 6 weeks during combination therapy. 4-6 weeks later subjects will undergo evaluation for response and surgical resection. | 28 | 44 | 10 | 43 | 43 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular and nodal arrhythmia:Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac general:Congestive heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CARDIAC ARRHYTHMIA: Cardiac arrest (Supraventricular and nodal arrhythmia: Atrial fibrillation) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea and vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cellulitis (skin infection) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Suicide | Social circumstances | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin (Anemia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils (Neutropenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total white blood count) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Platelets (Thrombocytopenia) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Supraventricular and nodal arrhythmia: multifocal atrial tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Supraventricular and nodal arrhythmia:Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Rigors | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
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| cardiac | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| (International Normalized Ratio of prothrombin time) | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Mucositis/Stomatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Heartburn (dyspepsia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Difficulty swallowing (dysphagia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Nose bleed | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Infection (not otherwise specified) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Colitis, infectious | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Pulmonary infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Upper airway infection (not otherwise specified) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Infection (Sepsis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Alkaline phosphatase (increase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| ALT/SGPT - serum glutamic pyruvic transaminase (increase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| AST/SGOT -serum glutamic oxaloacetic transaminase (increase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Creatinine (increase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Potassium, serum-low(hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Sodium, serum-low(hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Dizziness | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Cold sensitivity | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Mood alteration - Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Esophagus pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Abdomen pain (Not otherwise specified) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Jaw pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain NOS | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Pain swallowing (Odynophagia) | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Shortness of breath (dyspnea) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mary Mulcahy | Northwestern University | 312 695 6182 | Mary.Mulcahy@nm.org |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| 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 |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Progressive disease |
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| Death |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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