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Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer

NCT02497157 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-06-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Oxaliplatin (L-OHP)

DRUG

Irinotecan hydrochloride hydrate (CPT-11)

DRUG

Continuous intravenous infusion of fluorouracil (CIV 5-FU)

DRUG

Levofolinate calcium (l-LV)

DRUG

Bevacizumab (Bmab)

Sponsors & Collaborators

  • Hiroshima Prefectural Hospital

    collaborator UNKNOWN

  • National Hospital Organization Shikoku Cancer Center

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Katsunori Shinozaki, MD, Ph.D. · Hiroshima Prefectural Hospital

  • Tomohiro Nishina, MD, Ph.D. · National Hospital Organization Shikoku Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-21
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497157 on ClinicalTrials.gov