Spots Global Cancer Trial Database for S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
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Trial Identification
Brief Title: S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
Official Title: S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities
Study ID: NCT01416688
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * To establish psychometric properties for the Functional Assessment of Cancer Therapy Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion validity, known group's validity, internal consistency reliability, and responsiveness to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related toxicity. Secondary * To document minimally important differences over time for the FACT-EGFRI 18 by comparing mean changes in this PRO measure to the patient's direct assessment of change using two anchor items (change in skin condition severity and impact). * To examine the association between toxicity profiles (severity and time to onset), and treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores. * To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings. * To evaluate feasibility outcomes. 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States
East Bay Radiation Oncology Center, Castro Valley, California, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Epic Care-Dublin, Dublin, California, United States
Bay Area Breast Surgeons Inc, Emeryville, California, United States
Epic Care Partners in Cancer Care, Emeryville, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Los Angeles County-USC Medical Center, Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
El Camino Hospital, Mountain View, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Hematology and Oncology Associates-Oakland, Oakland, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California, United States
Saint Joseph Medical Center, Bloomington, Illinois, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Memorial Hospital of Carbondale, Carbondale, Illinois, United States
Illinois CancerCare-Carthage, Carthage, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Cancer Care Center of Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Eureka, Eureka, Illinois, United States
Little Company of Mary Hospital, Evergreen Park, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Illinois CancerCare-Macomb, Macomb, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States
OSF Saint Francis Medical Center, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Valley Radiation Oncology, Peru, Illinois, United States
Illinois CancerCare-Princeton, Princeton, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Springfield Clinic, Springfield, Illinois, United States
Memorial Medical Center, Springfield, Illinois, United States
Cancer Care Specialists of Illinois-Swansea, Swansea, Illinois, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Lawrence Memorial Hospital, Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal, Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Menorah Medical Center, Overland Park, Kansas, United States
Saint Luke's South Hospital, Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Via Christi Regional Medical Center, Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
University Health-Conway, Monroe, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport, Shreveport, Louisiana, United States
McLaren Cancer Institute-Flint, Flint, Michigan, United States
Singh and Arora Hematology Oncology PC, Flint, Michigan, United States
McLaren Cancer Institute-Lapeer Region, Lapeer, Michigan, United States
McLaren Cancer Institute-Macomb, Mount Clemens, Michigan, United States
McLaren Cancer Institute-Northern Michigan, Petoskey, Michigan, United States
Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States
Saint Francis Medical Center, Cape Girardeau, Missouri, United States
Southeast Cancer Center, Cape Girardeau, Missouri, United States
Centerpoint Medical Center LLC, Independence, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, United States
Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, United States
Research Medical Center, Kansas City, Missouri, United States
Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States
Liberty Radiation Oncology Center, Liberty, Missouri, United States
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States
Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States
Winthrop University Hospital, Mineola, New York, United States
Columbia University/Herbert Irving Cancer Center, New York, New York, United States
Cancer Care of Western North Carolina, Asheville, North Carolina, United States
Mission Hospital-Memorial Campus, Asheville, North Carolina, United States
Hope Women's Cancer Centers-Asheville, Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States
Carolinas HealthCare System NorthEast, Concord, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States
Wayne Memorial Hospital, Goldsboro, North Carolina, United States
Hendersonville Hematology and Oncology at Pardee, Hendersonville, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
High Point Regional Hospital, High Point, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States
Carolinas HealthCare System Union, Monroe, North Carolina, United States
Carolinas HealthCare System Cleveland, Shelby, North Carolina, United States
Southeastern Medical Oncology Center-Wilson, Wilson, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States
Contact Details
Name: Laurence H. Baker, DO, FACOI
Affiliation: University of Michigan Rogel Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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