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| ID | Type | Description | Link |
|---|---|---|---|
| S1013 | Other Identifier | SWOG | |
| U10CA037429 | U.S. NIH Grant/Contract | View source | |
| NCI-2011-02983 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.
PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*, 8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of papulopustular rash within 42 days are removed from study.
Investigators performing the patients' clinical assessment complete the EGFRI-Induced Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127, and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.
NOTE: *Patients start EGFRI therapy.
NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation and Questionnaires | Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| assessment of therapy complications | Procedure | Will be given by questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric properties of the FACT-EGFRI 18 | 127 days from registration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity and impact of skin symptoms | 127 days from registration | |
| Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items | 127 days from registration |
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DISEASE CHARACTERISTICS:
Patients must have a diagnosis of colorectal or lung cancer and be planning to receive one of the following epidermal growth factor receptor (HER1/EGFR) inhibitor therapies listed below for at least 6 weeks:
Patients must have completed the baseline S1013 Functional Assessment of Cancer Therapy- (FACT) EGFRI 18 within 7 days prior to registration
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Limited institutions from the SWOG membership.
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| Name | Affiliation | Role |
|---|---|---|
| Laurence H. Baker, DO, FACOI | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | United States | ||
| The University of Arizona Medical Center-University Campus |
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| psychosocial assessment and care | Procedure | Will be given by questionnaire |
|
| quality-of-life assessment | Procedure | Will be given by questionnaire |
|
| Associations between toxicity profile and treatment profiles | 127 days from registration |
| Feasibility as measured by accrual, time to specified accrual, time to complete forms | 2 years from study activation |
| Tucson |
| Arizona |
| 85724 |
| United States |
| East Bay Radiation Oncology Center | Castro Valley | California | 94546 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Epic Care-Dublin | Dublin | California | 94568 | United States |
| Bay Area Breast Surgeons Inc | Emeryville | California | 94608 | United States |
| Epic Care Partners in Cancer Care | Emeryville | California | 94608 | United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Los Angeles County-USC Medical Center | Los Angeles | California | 90033 | United States |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Contra Costa Regional Medical Center | Martinez | California | 94553-3156 | United States |
| El Camino Hospital | Mountain View | California | 94040 | United States |
| Highland General Hospital | Oakland | California | 94602 | United States |
| Alta Bates Summit Medical Center - Summit Campus | Oakland | California | 94609 | United States |
| Bay Area Tumor Institute | Oakland | California | 94609 | United States |
| Hematology and Oncology Associates-Oakland | Oakland | California | 94609 | United States |
| Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo | California | 94806 | United States |
| Saint Joseph Medical Center | Bloomington | Illinois | 61701 | United States |
| Illinois CancerCare-Bloomington | Bloomington | Illinois | 61704 | United States |
| Illinois CancerCare-Canton | Canton | Illinois | 61520 | United States |
| Memorial Hospital of Carbondale | Carbondale | Illinois | 62902 | United States |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Cancer Care Center of Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Heartland Cancer Research NCORP | Decatur | Illinois | 62526 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Little Company of Mary Hospital | Evergreen Park | Illinois | 60805 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Western Illinois Cancer Treatment Center | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Radiation Oncology of Northern Illinois | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center | Pekin | Illinois | 61554 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61603 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Radiation Oncology at Peoria Cancer Center | Peoria | Illinois | 61615 | United States |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Valley Radiation Oncology | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62702 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Springfield Clinic | Springfield | Illinois | 62703 | United States |
| Memorial Medical Center | Springfield | Illinois | 62781 | United States |
| Cancer Care Specialists of Illinois-Swansea | Swansea | Illinois | 62226 | United States |
| Cancer Center of Kansas - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | 66701 | United States |
| Cancer Center of Kansas-Independence | Independence | Kansas | 67301 | United States |
| Cancer Center of Kansas-Kingman | Kingman | Kansas | 67068 | United States |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | United States |
| Cancer Center of Kansas-Liberal | Liberal | Kansas | 67905 | United States |
| Cancer Center of Kansas-Manhattan | Manhattan | Kansas | 66502 | United States |
| Cancer Center of Kansas - McPherson | McPherson | Kansas | 67460 | United States |
| Cancer Center of Kansas - Newton | Newton | Kansas | 67114 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Saint Luke's South Hospital | Overland Park | Kansas | 66213 | United States |
| Cancer Center of Kansas - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas - Salina | Salina | Kansas | 67401 | United States |
| Cancer Center of Kansas - Wellington | Wellington | Kansas | 67152 | United States |
| Associates In Womens Health | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wichita NCI Community Oncology Research Program | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas - Winfield | Winfield | Kansas | 67156 | United States |
| University Health-Conway | Monroe | Louisiana | 71202 | United States |
| Louisiana State University Health Sciences Center Shreveport | Shreveport | Louisiana | 71103 | United States |
| McLaren Cancer Institute-Flint | Flint | Michigan | 48532 | United States |
| Singh and Arora Hematology Oncology PC | Flint | Michigan | 48532 | United States |
| McLaren Cancer Institute-Lapeer Region | Lapeer | Michigan | 48446 | United States |
| McLaren Cancer Institute-Macomb | Mount Clemens | Michigan | 48043 | United States |
| McLaren Cancer Institute-Northern Michigan | Petoskey | Michigan | 49770 | United States |
| Parkland Health Center-Bonne Terre | Bonne Terre | Missouri | 63628 | United States |
| Saint Francis Medical Center | Cape Girardeau | Missouri | 63703 | United States |
| Southeast Cancer Center | Cape Girardeau | Missouri | 63703 | United States |
| Centerpoint Medical Center LLC | Independence | Missouri | 64057 | United States |
| Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Heartland Hematology and Oncology Associates Incorporated | Kansas City | Missouri | 64118 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Saint Luke's East - Lee's Summit | Lee's Summit | Missouri | 64086 | United States |
| Liberty Radiation Oncology Center | Liberty | Missouri | 64068 | United States |
| Heartland Regional Medical Center | Saint Joseph | Missouri | 64506 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| Missouri Baptist Outpatient Center-Sunset Hills | Sunset Hills | Missouri | 63127 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Columbia University/Herbert Irving Cancer Center | New York | New York | 10032 | United States |
| Cancer Care of Western North Carolina | Asheville | North Carolina | 28801 | United States |
| Mission Hospital-Memorial Campus | Asheville | North Carolina | 28801 | United States |
| Hope Women's Cancer Centers-Asheville | Asheville | North Carolina | 28816 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | 28328 | United States |
| Carolinas HealthCare System NorthEast | Concord | North Carolina | 28025 | United States |
| Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | 27534 | United States |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | United States |
| Hendersonville Hematology and Oncology at Pardee | Hendersonville | North Carolina | 28791 | United States |
| Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| High Point Regional Hospital | High Point | North Carolina | 27261 | United States |
| Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | 28546 | United States |
| Carolinas HealthCare System Union | Monroe | North Carolina | 28112 | United States |
| Carolinas HealthCare System Cleveland | Shelby | North Carolina | 28150 | United States |
| Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina | 27893 | United States |
| Southeast Clinical Oncology Research (SCOR) Consortium NCORP | Winston-Salem | North Carolina | 27104 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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