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JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

ABSTRACT: Interventions: A: FTD/TPI monotherapy FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 and 8-12 in a 28-day cycle) B: Bi-weekly FTD/TPI+BEV combination Bi-weekly FTD/TPI (35 mg/m2 given orally twice daily on days 1-5 in a 14-day cycle) with BEV (5 mg/kg on day1, every 2 weeks) Primary outcome(s): Overall survival Study Design: randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose

DISEASE(S): Colorectal Cancer

PROVIDER: 2614546 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background and study aims Worldwide, nearly 1.25 million patients are diagnosed with colorectal cancer each year. At least 50% of patients develop metastases, and most of these patients have unresectable tumours (unable to be removed). Standard treatment for these patients involves chemotherapy and monoclonal antibodies targeting vascular endothelial growth factor (VEGF the cells that stimulate formation of blood vessels). In patients with KRAS wild-type tumours (abnormal tumours), monoclonal antibodies targeting epidermal growth factor receptor (EGFR which stimulates cell growth) are also used. 5-year survival rates in patients with metastatic colorectal cancer (mCRC), representing Stage IV CRC, were reached by only about 15% of mCRC patients. Although the outcome of patients with mCRC has clearly improved during recent years with median survival now reaching more than 30 months in recent clinical trials, more treatment options are needed for patients with disease progression after fluoropyrimidine (e.g. 5-FU), irinotecan, oxaliplatin, applicable anti-VEGF agents and anti-EGFR agents or those unable to tolerate these agents. Trifluridine/tipiracil (FTD/TPI; Lonsurf®) has been authorized in the EU since April 2016 for treatment of these patients. On the basis of the severity of the tumour disease with rather limited treatment options within the context of a previously treated tumour disease in the end-of-life situation, the health-related quality of life (HRQoL) is very important to describe the impact of treatment on the patient’s functioning regarding physical health (including disease-related morbidity), social, emotional, cognitive and role aspects. Changes of HRQoL during and after treatment with FTD/TPI have not been investigated so far in clinical trials. The aim of this study is to investigate the HRQoL in patients treated with FTD/TPI and those who are treated with best-supportive-care (BSC) while being suitable for treatment with FTD/TPI according to the summary of product characteristics. Who can participate? Adults aged 18 and older who have colorectal cancer. What does the study involve? Participants who are eligible for FTD/TPI therapy are treated like mCRC cancer patients in regular medical service receiving FTD/TPI with the only exemption that these cancer patients have to fill out 2 questionnaires (in total 36 questions) concerning their quality of life at treatment baseline and at the end of each FTD/TPI treatment cycle until end-of-treatment (i.e. disease progression).

Dataset Information

JCOG2014: Randomized phase III study of bi-weekly trifluridine/tipiracil plus bevacizumab vs trifluridine/tipiracil alone for chemorefractory metastatic colorectal cancer

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