title: A prospective observational study to examine the relationship between quality of life and adverse events of first-line chemotherapy plus cetuximab in patients with KRAS wild-type unresectable metastatic colorectal cancer: QUACK Trial.
abstract: We have planned a multicentre prospective study to examine the relative impact of the efficacy and adverse events of cetuximab plus first-line chemotherapy on the quality of life in Japanese patients with KRAS wild-type unresectable colorectal cancer. The Dermatology Life Quality Index and the European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 will be used to assess dermatology-specific and health-related quality of life. The severity of adverse events will be assessed by using the National Cancer Institute Common Terminology Criteria for adverse Events ver. 4.0. The endpoints will be the following associations: adverse events, including skin toxicity and quality of life; efficacy and skin toxicity; efficacy and quality of life; and skin-related quality of life and health-related quality of life. A total of 140 patients are considered to be appropriate for inclusion in this study. The results of this study will provide more information to both patients and physicians regarding the practical use of cetuximab and its impact on quality of life in patients with unresectable colorectal cancer in Japan. This study was registered at the University Hospital Medical Information Network Clinical Trial Registry as UMIN000010985.
authors.affiliation: *Department of Gastroenterology, Saitama Cancer Center, 818 Komuro, Ina Machi, Kita-Adachi-gun, Saitama 362-0806, Japan. akiraooki@cancer-c.pref.saitama.jp.
authors.forename: Akira
authors.initials: A
authors.lastname: Ooki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ando
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Atushi
authors.initials: A
authors.lastname: Sato
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Fujii
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D014408:Biomarkers, Tumor / Q000032:analysis*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives; D000068818:Cetuximab; D015179:Colorectal Neoplasms / Q000737:chemistry / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects; D006304:Health Status; D006801:Humans; D007564:Japan; D002955:Leucovorin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects; D011446:Prospective Studies; D011518:Proto-Oncogene Proteins / Q000032:analysis*; D016283:Proto-Oncogene Proteins p21(ras); D011788:Quality of Life; D018401:Sample Size; D012720:Severity of Illness Index; D012867:Skin / Q000187:drug effects*; D011795:Surveys and Questionnaires; D018631:ras Proteins / Q000032:analysis*
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D014408:Biomarkers, Tumor; C117307:KRAS protein, human; D009944:Organoplatinum Compounds; D011518:Proto-Oncogene Proteins; D016283:Proto-Oncogene Proteins p21(ras); D018631:ras Proteins; D000068818:Cetuximab; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: cetuximab; colorectal cancer; quality of life