Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-64105 | Other Identifier | Roswell Park Cancer Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, 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 together with 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 oxaliplatin and capecitabine together with radiation therapy works in treating patients undergoing surgery for stage II, stage III, or stage IV esophageal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients undergo tumor biopsies periodically. Collected samples are analyzed by gene expression studies, microarray analysis, and real-time quantitative reverse transcriptase-PCR to identify basal expression and changes in gene expression.
Quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemo | Experimental | Oxaliplatin 85 mg/m2 will be administered IV on days 1, 15 and 29. Capecitabine 1250 mg/m2 will be administered in 2 divided daily doses P0 or via enteral tube, on radiation days only (Monday- Friday/ weekly). Capecitabine will be continued until the final dose of radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | Oral |
| |
| oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | 5.5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1 | 5.5 weeks | |
| Median Time to Progression | 5.5 weeks | |
| Quality of Life Improved Rate |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
No known brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Life expectancy > 4 months
WBC > 4,000/mm³
ANC > 1,500/mm³
Platelet count > 100,000/mm³
Hemoglobin > 9 g/dL
Bilirubin normal
Creatinine normal
AST < 2.5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 3 times ULN
Able to take oral medication or undergo enteral administration of medication
No peripheral neuropathy ≥ grade 2
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 90 days after completion of study treatment
No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
No concurrent uncontrolled illness, including, but not limited to, any of the following:
No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
No known HIV or hepatitis B or C (active and/or previously treated)
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nikhil Khushalani, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy | Cycle 1: Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
IV |
|
| gene expression analysis | Genetic | Correlative Study |
|
| microarray analysis | Genetic | Correlative Study |
|
| reverse transcriptase-polymerase chain reaction | Genetic | Correlative Study |
|
| adjuvant therapy | Procedure | Metastatic growth control |
|
| biopsy | Procedure | Examination of tissue type |
|
| conventional surgery | Procedure | Tissue removal |
|
| neoadjuvant therapy | Procedure | Tumor shrinkage |
|
| quality-of-life assessment | Procedure | Correlative Study |
|
| radiation therapy | Radiation | Undergoing radiation therapy |
|
| 5.5 weeks |
| Treated With Study Therapy |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
treated patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy | Cycle 1: Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Complete Response | Evaluable Patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5.5 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After Course 1 | evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5.5 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Median Time to Progression | Evaluable patients | Posted | Number | 95% Confidence Interval | months | 5.5 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Quality of Life Improved Rate | evaluable patients | Posted | Number | 95% Confidence Interval | percentage of patients | 5.5 weeks |
|
|
Not provided
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 | COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy | Cycle 1: Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3. | 12 | 36 | 36 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion - Grade 3 | Cardiac disorders | Systematic Assessment |
| ||
| Pericarditis - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Intestinal obstruction - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal fistula - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal stenosis - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death - Grade 5 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 3 | General disorders | Systematic Assessment |
| ||
| Infection - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Wound infection - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Anastomotic leak - Grade 3 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Platelet count decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Flank pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Metastasis - Grade 4 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Aspiration - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism - Grade 4 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia - Grade 4 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Lymphopenia - Grade 4 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 2 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia - Grade 3 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Arrhythmia - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Palpitations - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Tachycardia - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Eye discharge - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Photopsia - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Vision blurred - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Visual disturbance - Grade 1 | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain upper - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ascites - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Eructation - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Flatulence - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth ulceration - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal pain - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal stenosis - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal stenosis - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophagitis - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatic insufficiency - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rectal haemorrhage - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Reflux oesophagitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Asthenia - Grade 1 | General disorders | Systematic Assessment |
| ||
| Asthenia - Grade 2 | General disorders | Systematic Assessment |
| ||
| Chest discomfort - Grade 1 | General disorders | Systematic Assessment |
| ||
| Chest pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Chest pain - Grade 2 | General disorders | Systematic Assessment |
| ||
| Chills - Grade 1 | General disorders | Systematic Assessment |
| ||
| Early satiety - Grade 2 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 1 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 2 | General disorders | Systematic Assessment |
| ||
| Fibrosis - Grade 2 | General disorders | Systematic Assessment |
| ||
| Infusion site reaction - Grade 1 | General disorders | Systematic Assessment |
| ||
| Injection site pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Injection site phlebitis - Grade 1 | General disorders | Systematic Assessment |
| ||
| Injection site phlebitis - Grade 2 | General disorders | Systematic Assessment |
| ||
| Injection site reaction - Grade 1 | General disorders | Systematic Assessment |
| ||
| Injection site reaction - Grade 2 | General disorders | Systematic Assessment |
| ||
| Malaise - Grade 2 | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 1 | General disorders | Systematic Assessment |
| ||
| Pain - Grade 1 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 1 | General disorders | Systematic Assessment |
| ||
| Pyrexia - Grade 2 | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome - Grade 3 | General disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 1 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 2 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 3 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypersensitivity - Grade 3 | Immune system disorders | Systematic Assessment |
| ||
| Bronchitis - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Candidiasis - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Eye infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Fungal infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Infection - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Opportunistic infection - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Anastomotic leak - Grade 1 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Incision site complication - Grade 3 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Seroma - Grade 1 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase - Grade 2 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase - Grade 2 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase - Grade 3 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Blood albumin decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood albumin decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood albumin decreased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood alkaline phosphatase increased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Blood bilirubin - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood bilirubin - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood calcium decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood calcium decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood calcium increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatine increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatine phosphokinase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatinine - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatinine - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood glucose decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood glucose increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood glucose increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood glucose increased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Blood potassium decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood potassium increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood potassium increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood sodium decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood sodium increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Haemoglobin - Grade 1 | Investigations | Systematic Assessment |
| ||
| Haemoglobin - Grade 2 | Investigations | Systematic Assessment |
| ||
| Haemoglobin - Grade 3 | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Haemoglobin decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Lymphocyte count decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Platelet count - Grade 1 | Investigations | Systematic Assessment |
| ||
| Platelet count decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Platelet count decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Transaminases increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Troponin I - Grade 3 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 3 | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| White blood cell count decreased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Anorexia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anorexia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Anorexia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gout - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypercalcaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypermagnesaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Back pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gouty arthritis - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gouty arthritis - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscular weakness - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dysaesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Headache - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Hyperaesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Neuroleptic malignant syndrome - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Neuropathy - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Peroneal nerve palsy - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Restless legs syndrome - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Tremor - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Vocal cord paralysis - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety disorder - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Depression - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Drug dependence - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Chromaturia - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute - Grade 1 | Renal and urinary disorders | Systematic Assessment |
| ||
| Aspiration - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Choking sensation - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chylothorax - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysphonia - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea exertional - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pharyngolaryngeal pain - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dermatitis - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Drug eruption - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Photosensitivity reaction - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash - Grade 3 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash generalised - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash macular - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin hyperpigmentation - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin lesion - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin odour abnormal - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis - Grade 3 | Vascular disorders | Systematic Assessment |
| ||
| Flushing - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Hypertension - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Hypertension - Grade 3 | Vascular disorders | Systematic Assessment |
| ||
| Hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Lymphorrhoea - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Phlebitis - Grade 2 | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Administrator, Compliance - Clinical Research Services | Roswell Park Cancer Institute | 716-845-2300 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| C562730 | Adenocarcinoma Of Esophagus |
| D000077277 | Esophageal Squamous Cell Carcinoma |
| 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 |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| D020869 | Gene Expression Profiling |
| D046228 | Microarray Analysis |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D017024 | Chemotherapy, Adjuvant |
| D001706 | Biopsy |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D046208 | Microchip Analytical Procedures |
| D016133 | Polymerase Chain Reaction |
| D021141 | Nucleic Acid Amplification Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
|
|
|