Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000306455 |
Not provided
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| NRG Oncology | OTHER |
Not provided
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RATIONALE: Drugs used in chemotherapy such as paclitaxel, fluorouracil, and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: This phase II trial is studying how well combination chemotherapy followed by chemoradiotherapy, with or without surgery, works in treating patients with resectable locally advanced cancer of the esophagus or gastroesophageal junction.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy.
Patients are followed periodically.
PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study within 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChemoRT and selective surgery | Experimental | Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | During induction therapy, patients ≤ 70 kg will receive 300 μg OR patients >70 kg will receive 480 μg subcutaneously on days 6-15 and 34-42. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (1-year Rate Reported) | One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20). | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Major (Grade 4) Acute Treatment-related Toxicities | From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery). | |
| Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection |
Not provided
DISEASE CHARACTERISTICS:
Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
No multiple primary carcinomas of the esophagus
No cervical esophageal carcinoma or tumors less than 5 cm from cricopharyngeus
No evidence of disseminated cancer
Bronchoscopy required for lesions less than 26 cm from the incisors to exclude tracheoesophageal fistula or invasion
No celiac adenopathy greater than 2 cm
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Stephen G. Swisher, MD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States | ||
| Saint Rose Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21507583 | Result | Swisher SG, Winter KA, Komaki RU, Ajani JA, Wu TT, Hofstetter WL, Konski AA, Willett CG. A Phase II study of a paclitaxel-based chemoradiation regimen with selective surgical salvage for resectable locoregionally advanced esophageal cancer: initial reporting of RTOG 0246. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1967-72. doi: 10.1016/j.ijrobp.2011.01.043. Epub 2011 Apr 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ChemoRT and Selective Surgery | Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| pegfilgrastim | Biological | During induction therapy, patients receive 6 mg subcutaneously on days 6 and 34. |
|
|
| cisplatin | Drug | During induction therapy, patients receive 15 mg/m^2/day by IV over 1 hour on days 1-5 and 29-33. During radiotherapy, patients receive 15 mg/m^2/day by IV over 1 hour beginning on days 57-61. |
|
| fluorouracil | Drug | During induction therapy, patients receive 650 mg/m^2/day by IV continuously over 96 hours beginning on days 1 and 29. During radiotherapy, patients receive 300 mg/m^2/day by IV continuously over 96 hours beginning on day 57 for 5 cycles. |
|
|
| paclitaxel | Drug | During induction therapy, patients receive 200 mg/m^2/day by IV over 2 hours on days 1 and 29. |
|
| conventional surgery | Procedure | Patients with residual or recurrent esophageal disease 4-6 weeks after completion of chemoradiotherapy may undergo salvage esophagectomy. |
|
| radiation therapy | Radiation | External beam radiotherapy with megavoltage linear accelerators (> 6 MV) will be used to deliver multiple (> 2) field techniques. Patients will be treated 5 days/week at 1.8 Gy/day for 28 days for a total dose of 50.4 Gy. |
|
| Analysis occurs with the primary outcome measure. |
| Hayward |
| California |
| 94545 |
| United States |
| Providence Holy Cross Cancer Center | Mission Hills | California | 91346-9600 | United States |
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Summit Medical Center | Oakland | California | 94609 | United States |
| Valley Care Medical Center | Pleasanton | California | 94588 | United States |
| J.C. Robinson, M.D. Regional Cancer Center | San Pablo | California | 94806 | United States |
| University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Hospital of Saint Raphael | New Haven | Connecticut | 06511 | United States |
| Baptist-South Miami Regional Cancer Program | Miami | Florida | 33176 | United States |
| Gulf Coast Cancer Treatment Center | Panama City | Florida | 32405 | United States |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia | 31403-3089 | United States |
| Mount Sinai Hospital Medical Center | Chicago | Illinois | 60608 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Wendt Regional Cancer Center at Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Ochsner Clinic of Baton Rouge | Baton Rouge | Louisiana | 708169990 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | 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 |
| Green Bay Oncology, Limited - Escanaba | Escanaba | Michigan | 49431 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Green Bay Oncology, Limited - Iron Mountain | Iron Mountain | Michigan | 49801 | United States |
| Foote Hospital | Jackson | Michigan | 49201 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48909 | United States |
| Seton Cancer Institute - Saginaw | Saginaw | Michigan | 48601 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Fairview Ridges Hospital | Burnsville | Minnesota | 55337 | United States |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | 55433 | United States |
| Fairview Southdale Hospital | Edina | Minnesota | 55435 | United States |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | 55432 | United States |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale | Minnesota | 55422-2900 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Park Nicollet Health Services | Saint Louis Park | Minnesota | 55416 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | United States |
| Hattiesburg Clinic, P.A. | Hattiesburg | Mississippi | 39401 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| Siteman Cancer Center at Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | United States |
| CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Fox Chase Virtua Health Cancer Program - Marlton | Marlton | New Jersey | 08053 | United States |
| Booker Cancer Center at Riverview Medical Center | Red Bank | New Jersey | 07701 | United States |
| Community Regional Cancer Center at Community Medical Center | Toms River | New Jersey | 08755 | United States |
| Albuquerque Regional Medical Center at Lovelace Sandia Health System | Albuquerque | New Mexico | 87102 | United States |
| University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-5636 | United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Wayne Radiation Oncology | Goldsboro | North Carolina | 27534 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Wilmed Radiation Oncology Services | Wilson | North Carolina | 27893 | United States |
| Akron City Hospital | Akron | Ohio | 44309-2090 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Middletown Regional Hospital | Middletown | Ohio | 45044 | United States |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem | Ohio | 44460 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Cancer Treatment Center | Wooster | Ohio | 44691 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Delaware County Regional Cancer Center at Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Paoli Memorial Hospital | Paoli | Pennsylvania | 19301-1792 | United States |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia | Pennsylvania | 19107-5541 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
| CCOP - MainLine Health | Wynnewood | Pennsylvania | 19096 | United States |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Rose Ramer Cancer Clinic at Anderson Area Medical 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 |
| M.D. Anderson Cancer Center at University of Texas | Houston | Texas | 77030-4009 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | 84112 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling | West Virginia | 26003 | United States |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay | Wisconsin | 54301-3526 | United States |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay | Wisconsin | 54303 | United States |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay | Wisconsin | 54303 | United States |
| St. Vincent Hospital Regional Cancer Center | Green Bay | Wisconsin | 54307-3508 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette | Wisconsin | 54143 | United States |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls | Wisconsin | 54154 | United States |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All eligible patients.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ChemoRT and Selective Surgery | Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy. |
| 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 |
| |||||||||||||||||
| Gender | 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 (1-year Rate Reported) | One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20). | All eligible patients. | Posted | Number | 95% Confidence Interval | percentage of participants | From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year. |
|
|
| |||||||||||||||||||||||||
| Secondary | Frequency of Major (Grade 4) Acute Treatment-related Toxicities | Not Posted | From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery). | Participants | ||||||||||||||||||||||||||||||||
| Secondary | Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection | Not Posted | Analysis occurs with the primary outcome measure. | Participants |
Not provided
Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events (AE). Data is reported for all registered patients.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ChemoRT and Selective Surgery | Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy. | 26 | 41 | 41 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Packed red blood cell transfusion | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Arrhythmia NOS | Cardiac disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Tracheo-oesophageal fistula NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Infection, Other | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dizziness (exc vertigo) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal failure NOS | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Adult respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Lung: NOS | Respiratory, thoracic and mediastinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pulmonary-other | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Thrombosis NOS | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Diarrhea NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophageal spasm | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Esophagitis NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Late RT Toxicity: Esophagus: NOS | Gastrointestinal disorders | RTOG/EORTC Late Tox. | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain due to radiation | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pain-other | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Infection NOS | Infections and infestations | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis radiation NOS | Injury, poisoning and procedural complications | CTC (2.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase NOS increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Leukopenia NOS | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Metabolic-Other | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Neutropenia | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | CTC (2.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood albumin decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Blood magnesium decreased | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypoglycaemia NOS | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dizziness (exc vertigo) | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Headache NOS | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Taste disturbance | Nervous system disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Insomnia NEC | Psychiatric disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Renal/GU-Other | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dyspnea NOS | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Dermatitis exfoliative NOS | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Localized exfoliation | Skin and subcutaneous tissue disorders | CTC (2.0) | Non-systematic Assessment |
| |
| Hypotension NOS | Vascular disorders | CTC (2.0) | Non-systematic Assessment |
|
PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wendy Seiferheld | NRG Oncology | seiferheldw@nrgoncology.org |
| 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 |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| C455861 | pegfilgrastim |
| C486981 | pegylated granulocyte colony-stimulating factor, human |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
Not provided
Not provided