Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Bone Density Conservation Agents

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Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

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Calcium, Dietary

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Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Patients receive FOLFOXIRI plus bevacizumab \[oxaliplatin (L-OHP): 85 mg/sq.m., irinotecan hydrochloride hydrate (CPT-11): 165 mg/sq.m., continuous intravenous infusion of fluorouracil (CIV 5-FU): 3,200 mg/sq.m., Levofolinate calcium (l-LV): 200 mg/sq.m., bevacizumab: 5 mg/kg\]. The treatment will be repeated every 2 weeks, for up to 12 cycles, unless the disease progression, unacceptable toxicity, tumor resection or consent withdrawal.

Oxaliplatin (L-OHP)

Irinotecan hydrochloride hydrate (CPT-11)

Continuous intravenous infusion of fluorouracil (CIV 5-FU)

Levofolinate calcium (l-LV)

Bevacizumab (Bmab)

Katsunori Shinozaki, MD, Ph.D.

Tomohiro Nishina, MD, Ph.D.

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.

Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer

Phase II Trial of FOLFOXIRI + Bevacizumab in Patients With Untreated Metastatic Colorectal Cancer

ETS will be calculated as the ratio of the number of eligible patients who experienced a 20% or more tumor shrinkage at week 8 compared with baseline.

DoR will be calculated as the median of the maximum tumor shrinkage rates.

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.

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.

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.

OS is defined as the time from date of starting treatment until date of death from any cause.

R0 resection rate will be calculated as the ratio of the number of eligible patients who experienced a complete (R0) resection.

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.

Hiroshima Prefectural Hospital

National Hospital Organization Shikoku Cancer Center

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer	NCT02497157	Metastatic Colo...	Oxaliplatin (L-... Irinotecan hydr... Continuous intr... Levofolinate ca... Bevacizumab (Bm...	20 Years - 70 Years	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer	NCT02497157	Metastatic Colo...	Oxaliplatin (L-... Irinotecan hydr... Continuous intr... Levofolinate ca... Bevacizumab (Bm...	20 Years - 70 Years	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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