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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-62705 | Other Identifier | Roswell Park Cancer Institute |
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RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving erlotinib together with radiation therapy works in treating older patients with stage I, stage II, stage III, or stage IV esophageal cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo external beam radiotherapy 5 days a week in weeks 1-4 or 5 days a week for the first 5.5 weeks.
Tumor tissue samples are analyzed by IHC for the expression of E-cadherin, P-cadherin, vimentin, cytokeratin, phospho-S6, and Ki67.
After completion of study treatment, patients are followed at 30 days and annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Erlotinib | Experimental | Patients receive oral erlotinib hydrochloride once daily for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib hydrochloride | Drug | Oral |
| |
| immunohistochemistry staining method |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor. | 4-8 weeks after completion of radiation. |
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DISEASE CHARACTERISTICS:
Biopsy-proven primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
GE junction tumors with 50% or more tumor located in the esophagus determined by radiologic or endoscopic evaluation
Stage I-IVA disease determined by CT scan or MRI of the chest and abdomen
Not a surgical candidate and ineligible for chemotherapy due to any of the following:
Bronchoscopy with biopsy and cytology required if primary esophageal cancer is < 26 cm from incisors
No evidence of clinically active interstitial lung disease (patients who are asymptomatic with chronic, stable, radiographic lung changes allowed)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Renuka Iyer, 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erlotinib in Combination With Radiotherapy | Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Other |
Correlative Study |
|
| radiation therapy | Radiation | Radiation Treatment |
|
| Progresssion-Free Survival | Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Every 3 months, up to 5 years |
| Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale | Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes | Baseline and Week 3 |
| Correlation of Smoking Status With Overall Survival | 5 years |
| Response by Epidermal Growth Factor Receptor (EGFR) Expression | Radiologic evaluation every 3 months, up to 5 years |
| Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression | Radiologic evaluation every 3 months, up to 5 years |
| Response by EGFR Mutation Status | Radiologic evaluation every 3 months, up to 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All Treated Patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Erlotinib in Combination With Radiotherapy | Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction. |
| 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 | Overall Survival | Posted | Median | 95% Confidence Interval | months | 5 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Complete Response | Response assessment by CT scans and upper endoscopy performed between 4-8 weeks after completion of radiation. Complete Response (CR) is defined as absence of viable tumor in endoscopic evaluation post chemoradiation, with four-quadrant biopsies taken at 1 cm intervals throughout length of original tumor. | Patients Treated with Study Therapy | Posted | Number | 95% Confidence Interval | percentage of participants | 4-8 weeks after completion of radiation. |
|
| ||||||||||||||||||||||||||
| Secondary | Progresssion-Free Survival | Progression is defined as at least a 20% increase in the sum of long distance of target lesions taking as reference the smallest sum long distance recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. | Posted | Median | 95% Confidence Interval | months | Every 3 months, up to 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Effect of Study Therapy on Overall Quality of Life as Assessed by FACT-E Scale | Functional Assessment of Cancer Therapy-Esophagus (FACT-E) is a health-related quality of life instrument validated in esophageal cancer patients. All of the scales and single-item measures range in score from 0 to 4. The ranges of average quality of life scores was from 0 to 4 and was adjusted as lower scores indicate better outcomes | Patients Treated with Study Therapy and with FACT-E scores available | Posted | Median | Full Range | FACT-E Score | Baseline and Week 3 |
|
| ||||||||||||||||||||||||||
| Secondary | Correlation of Smoking Status With Overall Survival | Patients Treated with Study Therapy | Posted | Median | 95% Confidence Interval | months | 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Response by Epidermal Growth Factor Receptor (EGFR) Expression | Posted | Number | participants | Radiologic evaluation every 3 months, up to 5 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Response by Phosphor Epidermal Growth Factor Receptor (pEGFR) Expression | Posted | Number | participants | Radiologic evaluation every 3 months, up to 5 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Response by EGFR Mutation Status | Posted | Number | participants | Radiologic evaluation every 3 months, up to 5 years |
|
|
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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 | Erlotinib in Combination With Radiotherapy | Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction. | 9 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive - Grade 5 | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction - Grade 4 | Cardiac disorders | Systematic Assessment |
| ||
| Diarrhoea - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal stenosis - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Death - Grade 5 | General disorders | Systematic Assessment |
| ||
| Fatigue - Grade 3 | General disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain - Grade 3 | General disorders | Systematic Assessment |
| ||
| Pneumonia - Grade 3 | Infections and infestations | Systematic Assessment |
| ||
| Haemoglobin - Grade 2 | Investigations | Systematic Assessment |
| ||
| Dehydration - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Pain in extremity - Grade 3 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nervous system disorder - Grade 4 | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnoea - Grade 4 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress - Grade 3 | 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 |
| ||
| Leukopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia - Grade 2 | 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 |
| ||
| Thrombocytopenia - Grade 1 | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute myocardial infarction - Grade 4 | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris - Grade 1 | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris - Grade 2 | Cardiac disorders | Systematic Assessment |
| ||
| Ventricular arrhythmia - Grade 4 | Cardiac disorders | Systematic Assessment |
| ||
| Vision blurred - Grade 3 | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chapped lips - Grade 1 | 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 |
| ||
| 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 |
| ||
| Gastritis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal reflux disease - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired gastric emptying - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Odynophagia - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oesophageal obstruction - Grade 3 | 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 |
| ||
| Reflux oesophagitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Reflux oesophagitis - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retching - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Stomatitis - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting - Grade 2 | Gastrointestinal 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 |
| ||
| Fatigue - Grade 3 | General disorders | Systematic Assessment |
| ||
| Mucosal inflammation - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 1 | General disorders | Systematic Assessment |
| ||
| Oedema peripheral - Grade 2 | General disorders | Systematic Assessment |
| ||
| Pain - Grade 2 | General disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 1 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperbilirubinaemia - Grade 2 | Hepatobiliary disorders | Systematic Assessment |
| ||
| Fungal skin infection - Grade 1 | Infections and infestations | Systematic Assessment |
| ||
| Fungal skin infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection - Grade 2 | Infections and infestations | Systematic Assessment |
| ||
| Contusion - Grade 1 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Facial bones fracture - Grade 2 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Procedural site reaction - Grade 2 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rib fracture - Grade 2 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Skin laceration - Grade 2 | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Alanine aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Aspartate aminotransferase increased - Grade 2 | 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 bilirubin - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood bilirubin - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood bilirubin increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood calcium decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatine - Grade 2 | Investigations | Systematic Assessment |
| ||
| Blood creatine increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatinine - Grade 1 | Investigations | Systematic Assessment |
| ||
| Blood creatinine - Grade 2 | Investigations | Systematic Assessment |
| ||
| Haemoglobin - Grade 1 | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased - Grade 1 | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased - Grade 2 | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased - Grade 3 | Investigations | Systematic Assessment |
| ||
| Platelet count decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Troponin I increased - Grade 4 | Investigations | Systematic Assessment |
| ||
| Weight decreased - Grade 1 | Investigations | Systematic Assessment |
| ||
| Weight 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 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dehydration - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gout - Grade 2 | 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 |
| ||
| Hyperkalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypernatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesaemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatraemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Buttock pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Gouty arthritis - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Groin pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal chest pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain - Grade 2 | 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 |
| ||
| Dizziness - Grade 2 | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Headache - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Syncope - Grade 3 | Nervous system disorders | Systematic Assessment |
| ||
| Tremor - Grade 1 | Nervous system disorders | Systematic Assessment |
| ||
| Depression - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Depression - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia - Grade 1 | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia - Grade 2 | Psychiatric disorders | Systematic Assessment |
| ||
| Pollakiuria - Grade 2 | Renal and urinary disorders | Systematic Assessment |
| ||
| Cough - Grade 1 | 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 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis - Grade 2 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hiccups - Grade 1 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Decubitus ulcer - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis acneiform - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dermatitis acneiform - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Drug eruption - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Drug eruption - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyperhidrosis - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Palmar-plantar erythrodysaesthesia syndrome - Grade 2 | 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 pruritic - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin disorder - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin exfoliation - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis - Grade 3 | Vascular disorders | Systematic Assessment |
| ||
| Hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
| ||
| Hypotension - Grade 4 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 1 | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
|
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| 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 |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D007150 | Immunohistochemistry |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D013812 | Therapeutics |
Not provided
Not provided
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| Participants |
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