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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02678 | Registry Identifier | CTRP (Clinical Trials Reporting System) | |
| CDR0000455635 | Registry Identifier | PDQ (Physician Data Query) |
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Trial closed early because, during an interim analysis, the primary endpoint fell short.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as pemetrexed disodium and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with pemetrexed disodium and carboplatin 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 radiation therapy together with pemetrexed disodium and carboplatin works in treating patients with locally advanced esophageal cancer that can be removed by surgery.
OBJECTIVES:
Primary
* Determine the pathologic complete response rate of radiotherapy, pemetrexed disodium, and carboplatin when administered prior to esophagectomy in patients with locally advanced esophageal cancer.
Secondary
Quality of life is assessed at baseline, immediately prior to day 22 of chemotherapy, and within 2 weeks prior to surgery.
After completion of study treatment, patients are followed periodically for approximately 4 years.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pemetrexed/Carboplatin | Experimental | Pemetrexed+Carboplatin+Radiation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response Rate | The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable. | Baseline to time of surgery (around 10 - 18 weeks post-baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from registration to death due to any cause. | From baseline to 4 years |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction
No T1-2, N0, M0 disease
No palpable or biopsy-proven involvement of supraclavicular nodes or radiographically involved supraclavicular nodes (> 1.5 cm in greatest dimension) for lesions in mid-thoracic, distal thoracic, or GE junction
+ Supraclavicular node involvement allowed provided there are upper thoracic esophagus primary lesions
Patients with involvement of celiac nodes (stations 15-20) are eligible if the primary lesion is mid-thoracic, distal esophagus, or GE junction
No evidence of distant metastases
Tumor must be considered surgically resectable
- Patients with T4, N0 tumors that are potentially resectable are eligible
No clinically relevant pleural or peritoneal effusion that is not amenable to drainage
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, MD | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Scottsdale | Scottsdale | Arizona | 85259-5499 | United States | ||
| Mayo Clinic - Jacksonville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20975604 | Result | Jatoi A, Soori G, Foster NR, Hiatt BK, Knost JA, Fitch TR, Callister MD, Nichols FC 3rd, Husted TM, Alberts SR. Phase II study of preoperative pemetrexed, carboplatin, and radiation followed by surgery for locally advanced esophageal cancer and gastroesophageal junction tumors. J Thorac Oncol. 2010 Dec;5(12):1994-8. doi: 10.1097/JTO.0b013e3181fb5c3e. | |
| 21892283 |
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This trial closed early because, during an interim analysis, the primary endpoint fell short. However, 26 eligible patients were accrued. Due to early closure not all the endpoints were analyzed.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pemetrexed/Carboplatin | Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field). Conventional surgery |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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| Pemetrexed | Drug | Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. |
|
| conventional surgery | Procedure |
|
| neoadjuvant therapy | Procedure |
|
| radiation therapy | Radiation | Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field). |
|
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| Graham Hospital | Canton | Illinois | 61520 | United States |
| Memorial Hospital | Carthage | Illinois | 62321 | United States |
| St. Anthony's Memorial Hospital | Effingham | Illinois | 62401 | United States |
| Eureka Community Hospital | Eureka | Illinois | 61530 | United States |
| Galesburg Clinic, PC | Galesburg | Illinois | 61401 | United States |
| Galesburg Cottage Hospital | Galesburg | Illinois | 61401 | United States |
| InterCommunity Cancer Center of Western Illinois | Galesburg | Illinois | 61401 | United States |
| Mason District Hospital | Havana | Illinois | 62644 | United States |
| Hopedale Medical Complex | Hopedale | Illinois | 61747 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Kewanee Hospital | Kewanee | Illinois | 61443 | United States |
| McDonough District Hospital | Macomb | Illinois | 61455 | United States |
| BroMenn Regional Medical Center | Normal | Illinois | 61761 | United States |
| Community Cancer Center | Normal | Illinois | 61761 | United States |
| Community Hospital of Ottawa | Ottawa | Illinois | 61350 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | 61350 | United States |
| Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | 61554 | United States |
| Proctor Hospital | Peoria | Illinois | 61614 | United States |
| CCOP - Illinois Oncology Research Association | Peoria | Illinois | 61615 | United States |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | 61615 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61636 | United States |
| Illinois Valley Community Hospital | Peru | Illinois | 61354 | United States |
| Perry Memorial Hospital | Princeton | Illinois | 61356 | United States |
| St. Margaret's Hospital | Spring Valley | Illinois | 61362 | United States |
| Valley Cancer Center | Spring Valley | Illinois | 61362 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | 52403 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101 | United States |
| Mercy Medical Center - Sioux City | Sioux City | Iowa | 51104 | United States |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Foote Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Albert Lea Cancer Center at Albert Lea Medical Center | Albert Lea | Minnesota | 56007 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Hutchinson Area Health Care | Hutchinson | Minnesota | 55350 | United States |
| Meeker County Memorial Hospital | Lichfield | Minnesota | 55355 | United States |
| HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | 55109 | United States |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | 55415 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Cancer Center | Saint Louis Park | Minnesota | 55416 | United States |
| Regions Hospital Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| HealthEast Cancer Care at St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | 55125 | United States |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | 55125 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | United States |
| Medical X-Ray Center, PC | Sioux Falls | South Dakota | 57105 | United States |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | 57117-5039 | United States |
| Katipamula R, Jatoi A, Foster NR, Nichols F, Rubin J, Callister M, Gunderson L, Alberts S. Pemetrexed, Carboplatin, and Concomitant Radiation followed by Surgery for Locally Advanced Esophageal Cancer: Results of a Planned Interim Toxicity Analysis of North Central Cancer Treatment Group Study N044E. Clin Med Oncol. 2008;2:223-5. doi: 10.4137/cmo.s444. Epub 2008 Apr 1. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pemetrexed/Carboplatin | Pemetrexed+Carboplatin+Radiation> > carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.> > Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.> > conventional surgery> > neoadjuvant therapy> > radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field). |
| 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 |
| ||||||||||||||||||
| 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 | Pathologic Complete Response Rate | The proportion of pathologic complete responses will be estimated by the number of pathologic complete responses divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true pathologic complete response rate will be calculated. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for Measurable disease is defined as at least one lesion whose longest diameter can be accurately measured as ≥2.0 cm with conventional techniques or as ≥1.0 cm with spiral CT. Lesions on chest x-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to time of surgery (around 10 - 18 weeks post-baseline) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Time from registration to death due to any cause. | Posted | Median | 95% Confidence Interval | months | From baseline to 4 years |
|
|
Not provided
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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 | Pemetrexed/Carboplatin | Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field). Conventional surgery | 6 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal fistula | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Leukocyte count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 6 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 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 |
| |
| Renal failure | Renal and urinary disorders | MedDRA 6 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | MedDRA 6 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Myocardial ischemia | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 6 | Systematic Assessment |
| |
| Pericarditis | Cardiac 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 |
| |
| Esophageal mucositis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophageal pain | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Oesophagoscopy abnormal | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Death NOS | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Edema limbs | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 6 | Systematic Assessment |
| |
| Endocarditis infective | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Small intestine infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 6 | Systematic Assessment |
| |
| Esophageal anastomotic leak | Injury, poisoning and procedural complications | MedDRA 6 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | 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 |
| |
| 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 glucose decreased | 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 |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 6 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 6 | Systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Atelectasis | 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 |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 6 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 6 | Systematic Assessment |
| |
| Erythema multiforme | 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 |
| |
| Hypotension | Vascular disorders | MedDRA 6 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 6 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | 507/284-4918 | jatoi.aminah@mayo.edu |
| 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 |
|---|---|
| D016190 | Carboplatin |
| D000068437 | Pemetrexed |
| D020360 | Neoadjuvant Therapy |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
|