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| ID | Type | Description | Link |
|---|---|---|---|
| IND 65889 |
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Patients with surgically resectable T1N1M0 or T2-4N any M0 esophageal carcinoma will receive six weeks of induction chemotherapy with weekly irinotecan and cisplatin given weeks 1, 2, 4 and 5. Patients will then receive weekly irinotecan, cisplatin, and concurrent radiotherapy with chemotherapy given once weekly, weeks 8,9,11 and 12 during the six weeks of radiotherapy. Patients will be referred for surgery 4-8 weeks after completion of chemoradiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | External Beam Radiation Therapy, Cisplatin, Irinotecan |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | pts will receive weekly cisplatin 30mg/m2 after hydration on weeks 8,9,11 and 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Ilson, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Modality Therapy for Esophageal Carcinoma | The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Irinotecan |
| Drug |
Irinotecan will be given 65 mg/m2 |
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| External Beam Radiation Therapy | Radiation | will be delivered with multiple (>2) field techniques using mega-voltage radiation therapy. pts will receive 50.4 Gy and will be treated over a 6 week period. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Modality Therapy for Esophageal Carcinoma | The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | Pathologic Complete Response | Pathological information will be available for all patients who receive surgery. If a patient is deemed unresectable based on clinical and radiological examination after the therapy, that patient will be counted as non-responder. The best overall response is the best response recorded from the start of treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria. We will also estimate the pathological complete response rates separately for each of these tumor types. Survival and disease-free survival will be estimated using Kaplan-Meier method. With an accrual rate of 3 patients a month, we expect the study to be completed in 18 months. | Posted | Number | participants | 2 years |
|
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| Secondary | Evaluate Toxicity and Tolerability Including Surgical Morbidity and Mortality | Posted | Number | participants | 2 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 | Combined Modality Therapy for Esophageal Carcinoma | The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia. | 22 | 55 | 55 | 55 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Cardiovascular, Arrhythmia other | Cardiac disorders | Systematic Assessment |
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| Chest pain | Cardiac disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dehydration | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea (Pts w/out col) | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia, esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia-esophageal | Gastrointestinal disorders | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophil count decr | Investigations | Systematic Assessment |
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| Phlebitis | Vascular disorders | Systematic Assessment |
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| Platelet count decreased | Investigations | Systematic Assessment |
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| Syncope | Nervous system disorders | Systematic Assessment |
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| Thrombosis | Vascular disorders | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Investigations | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| Bilirubin | Investigations | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Creatinine | Investigations | Systematic Assessment |
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| Diarrhea (Pts w/out col) | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia, esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia-esophageal | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hemoglobin (Hgb) | Blood and lymphatic system disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Leukocytes | Blood and lymphatic system disorders | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophils/gran | Investigations | Systematic Assessment |
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| PT | Investigations | Systematic Assessment |
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| PTT | Investigations | Systematic Assessment |
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| Platelets | Investigations | Systematic Assessment |
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| SGOT (AST) | Investigations | Systematic Assessment |
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| SGPT (ALT) | Investigations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Ilson, Attending | Memorial Sloan Kettering Cancer Center | +1646-888-4183 | ilsond@mskcc.org |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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