The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) \*1/\*1, \*1/\*6 or \*1/\*28.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Kagawa University Hospital
Kita-gun, Miki-cho, Kagawa-ken, Japan
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, Japan
Okayama Saiseikai General Hospital
Okayama, Okayama-ken, Japan
Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1)
RR will be calculated as the ratio of the number of eligible patients who experienced a confirmed Complete response(CR) or Partial response(PR) by RECIST v1.1.
Time frame: Up to 18 months
Time to treatment failure (TTF)
TTF is defined as the time from date of starting treatment until date of treatment discontinuation, the first documented progression or death from any cause, whichever comes first.
Time frame: Up to 18 months
Progression-free survival (PFS)
PFS is defined as the time from date of starting treatment until date of the first documented progression or death from any cause, whichever comes first.
Time frame: Up to 3 years
Overall survival (OS)
OS is defined as the time from date of starting treatment until date of death from any cause.
Time frame: Up to 3 years
R0 resection rate
R0 resection rate will be calculated as the ratio of the number of eligible patients who experienced a complete (R0) resection.
Time frame: Up to 18 months
Relative dose intensity (RDI)
RDI will be calculated as the ratio of actual delivered dose intensity in comparison with planned dose intensity. Dose intensity (DI) is defined as the amount of drug delivered per unit time, expressed in mg/m2/week.
Time frame: Up to 18 months
Incidence of adverse events
Time frame: Up to 3 years
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Okayama University Hospital
Okayama, Okayama-ken, Japan
Okayama Rosai Hospital
Okayama, Okayama-ken, Japan
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima, Japan