A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC

Summary

The primary purpose of this study is to determine the non-inferiority of overall survival XELIRI with or without Bevacizumab compared with FOLFIRI with or without Bevacizumab as Second-line therapy in Patient with Metastatic Colorectal Cancer.

Conditions

• Colorectal Neoplasms
• Neoplasm Metastasis
• Intestinal Neoplasms
• Gastrointestinal Neoplasms
• Digestive System Neoplasms

Interventions

BIOLOGICAL

Bevacizumab

5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.

DRUG

CPT-11 (Irinotecan)

150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle.

DRUG

5-FU Bolus

400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.

DRUG

5-FU Infusion

2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.

DRUG

l-LV (dl-LV)

200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.

BIOLOGICAL

bevacizumab

7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle.

DRUG

CPT-11 (Irinotecan)

150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle.

DRUG

Capecitabine

1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle.

Sponsors & Collaborators

• Epidemiological and Clinical Research Information Network

  lead OTHER

Principal Investigators

• Kei Muro, MD · Aichi Cancer Center Hospital, Japan

• Tae Won Kim, MD, PhD · ASAN Medical center, South Korea

• Young Suk Park, MD, PhD · Samsung Medical Center, South Korea

• Ruihua Xu, MD, PhD · Sun Yat-Sen University Cancer Center, China

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-12-02

Primary Completion

2017-11-20

Completion

2018-06-30

Countries

• Japan

Study Locations