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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000468495 | Registry Identifier | NCI Physician Data Query | |
| NCI-2009-00491 | Registry Identifier | NCI Clinical Trial Reporting Program | |
| U10CA180821 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery. Drugs used in chemotherapy, such as cisplatin and irinotecan hydrochloride, 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 combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PRIMARY OBJECTIVES:
I. To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan (irinotecan hydrochloride) followed by concurrent cisplatin/irinotecan and radiation therapy.
SECONDARY OBJECTIVES:
I. To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography (PET) scan.
II. To evaluate the toxicity and tolerability of therapy, including surgical morbidity and mortality.
III. To determine the overall survival, disease free survival, and pattern of failure.
OUTLINE:
INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (chemotherapy, chemoradiotherapy, surgery) | Experimental | INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin intravenously (IV) over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Given IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery | A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Utility of Early PET Imaging in Predicting Response to Treatment | Up to 55 days | |
| Disease-free Survival | Up to 5 years | |
| Overall Survival |
Not provided
Histologically or cytologically confirmed adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal junction; biopsy or cytology of the primary tumor, or of involved regional lymph nodes, is acceptable
Tumors must be TNM stage T2-4, N0-1, M0 as determined by pretreatment endoscopic ultrasound; T1 tumors are eligible if they are T1, N1, M0; regional thoracic lymph node involvement (N1) is permitted
Disease must be clinically limited to the esophagus or gastroesophageal junction; if the tumor extends below the gastroesophageal junction into the proximal stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal junction; adenocarcinomas of the distal esophagus would therefore include tumors of the distal esophagus, or Siewert type I according to the Siewert classification, and tumors of the gastroesophageal junction which involve equally both the distal esophagus and proximal stomach, or Siewert type II; tumor must be surgically resectable
Patients with evidence of metastatic disease are not eligible; this includes:
No prior chemotherapy or radiotherapy is permitted; patients must be at least 4 weeks since major surgery, or must have recovered from the effects of minor surgery (laparoscopy, thoracoscopy)
No prior malignancies (other than basal cell/squamous carcinoma of the skin, in-situ cervical carcinoma, or superficial transitional cell bladder carcinoma) are permitted unless diagnosed and/or treated >= 3 years before registration and without evidence of recurrence
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No evidence of recurrent laryngeal nerve or phrenic nerve paralysis
No known Gilbert's disease
No clinically significant hearing loss; audiograms should be done in patients in which they are clinically indicated
No history of active seizure disorder; no ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication; patients who are receiving valproic acid are eligible
No New York Heart Association class III or IV heart disease; no angina or myocardial infarction within the last 6 months
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H. Ilson, MD, PhD | Memorial Sloan Kettering Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elkhart General Hospital | Elkhart | Indiana | 46515 | United States | ||
| Howard Community Hospital |
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Between February 2006 and August 2011, 82 participants were recruited to this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Chemotherapy, Chemoradiotherapy, Surgery) | INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| irinotecan hydrochloride |
| Drug |
Given IV |
|
| therapeutic conventional surgery | Procedure | Undergo Surgery |
|
| radiation therapy | Radiation | Undergo radiation |
|
|
| Up to 5 years |
| Patterns of Failure | Up to 5 years |
| Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis | Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | Up to 5 years |
| Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity | Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0 | Up to 5 years |
| Kokomo |
| Indiana |
| 46904 |
| United States |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana | 46350 | United States |
| Saint Joseph Regional Medical Center | Mishawaka | Indiana | 46545-1470 | United States |
| CCOP - Northern Indiana CR Consortium | South Bend | Indiana | 46601 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Michiana Hematology-Oncology, PC - South Bend | South Bend | Indiana | 46601 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| CancerCare of Maine at Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Center for Cancer Medicine and Blood Disorders - Scarborough | Scarborough | Maine | 04074 | United States |
| Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan | 49085 | United States |
| Methodist Estabrook Cancer Center | Omaha | Nebraska | 68114 | United States |
| New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care | Concord | New Hampshire | 03301 | United States |
| New Hampshire Oncology - Hematology, PA - Hooksett | Hooksett | New Hampshire | 03106 | United States |
| Lakes Region General Hospital | Laconia | New Hampshire | 03246 | United States |
| Elliot Regional Cancer Center at Elliot Hospital | Manchester | New Hampshire | 03103 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210-1240 | United States |
| Mountainview Medical | Berlin Corners | Vermont | 05602 | United States |
| Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | 05401 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Chemotherapy, Chemoradiotherapy, Surgery) | INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients With Adenocarcinoma Achieving a Pathologic Complete Response (CR) After Surgery | A pathological complete response is defined as no tumor found on pathology review at surgery in all resected lymph nodes and tissue. All tissues sampled must have NO viable tumor | 27 participants with adenocarcinoma were recruited and evaluated for the primary outcome per protocol design. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 5 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Utility of Early PET Imaging in Predicting Response to Treatment | Not Posted | Up to 55 days | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Disease-free Survival | Not Posted | Up to 5 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Not Posted | Up to 5 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Patterns of Failure | Not Posted | Up to 5 years | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Experiencing Grade 3 or Greater Pneumonitis or Esophagitis | Proportion of patients experiencing grade 3 or greater pneumonitis or esophagitis, deemed at least possibly related to treatment graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 | 1 participant was not evaluated for adverse events. | Posted | Number | percentage of participants | Up to 5 years |
|
| |||||||||||||||||||||||||||
| Secondary | Proportion of Patients Experiencing Grade 3 or Greater Hematologic and Non-hematologic Toxicity | Proportion of patients experiencing grade 3 or greater hematologic and non-hematologic toxicity, deemed as at least possibly related to treatment, graded using the NCI CTCAE version 3.0 | 1 participant was not evaluated for adverse events. | Posted | Number | percentage of participants | 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 | Treatment (Chemotherapy, Chemoradiotherapy, Surgery) | INDUCTION CHEMOTHERAPY (COURSES 1-2): Patients receive cisplatin 30 mg/m^2 intravenously (IV) over 30 minutes and irinotecan hydrochloride 65 mg/m^2 IV over 30-90 minutes on days 1 and 8 of courses 1 and 2. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. CHEMORADIOTHERAPY (COURSES 3-4): Beginning 2 weeks after completion of induction chemotherapy, patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo surgery to remove the tumor. | 6 | 81 | 80 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemolysis | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Flashing vision | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 6 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal stenosis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Tooth development disorder | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fever | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Infective myositis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Paranasal sinus infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Prolonged intubation after pulmonary resection (>24 hrs after surgery) | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Coagulopathy | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum calcium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | MedDRA 6 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness lower limb | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Euphoria | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Bladder pain | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Urogenital disorder | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 6 | Systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Hemorrhage | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hot flashes | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David H. Ilson, M.D., Ph.D. | Memorial Sloan-Kettering Cancer Center | ilsond@mskcc.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077146 | Irinotecan |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D055585 | Physical Phenomena |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|