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
| Autor: | Masahiko Ando, Hirofumi Fujii, Atushi Sato, Junichi Sakamoto, Akira Ooki, Kensei Yamaguchi |
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| Rok vydání: | 2014 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Organoplatinum Compounds Colorectal cancer Health Status Leucovorin Cetuximab Antibodies Monoclonal Humanized Severity of Illness Index Proto-Oncogene Proteins p21(ras) Japan Quality of life Proto-Oncogene Proteins Surveys and Questionnaires Internal medicine Antineoplastic Combined Chemotherapy Protocols Biomarkers Tumor medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Adverse effect Aged Skin business.industry Cancer Common Terminology Criteria for Adverse Events General Medicine Dermatology Life Quality Index Middle Aged medicine.disease Clinical trial Sample Size Quality of Life ras Proteins Camptothecin Female Fluorouracil Colorectal Neoplasms business medicine.drug |
| Zdroj: | Japanese Journal of Clinical Oncology. 44:383-387 |
| ISSN: | 1465-3621 0368-2811 |
| DOI: | 10.1093/jjco/hyu008 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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