MedTrace Logo

A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC

NCT03303495 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2017-10-06

No results posted yet for this study

Summary

The primary purpose of this study is to determine the non-inferiority of overall survival FOLFIRI with or without Bevacizumab compared with Irinotecan (CPT-11) 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

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-14
Primary Completion
2017-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03303495 on ClinicalTrials.gov