RecruitingPhase 3NCT03303495

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

A Multinational, Randomized, Phase III Study of FOLFIRI With/Without Bevacizumab Versus Irinotecan With/Without Bevacizumab As Second-line Therapy in Patients With Metastatic Colorectal Cancer


Sponsor

Sun Yat-sen University

Enrollment

280 participants

Start Date

Nov 14, 2011

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 5-FU Bolus, a drug called 5-FU Infusion, and others for people with colorectal neoplasms, digestive system neoplasms, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBevacizumab

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.

DRUGCPT-11

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

DRUG5-FU Bolus

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

DRUG5-FU Infusion

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

DRUGl-LV (dl-LV)

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


Locations(1)

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT03303495


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