Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin

June 4, 2019 updated by: Ping Lan, Sixth Affiliated Hospital, Sun Yat-sen University

Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment

Colorectal cancer (CRC) is one of the most leading causes of cancer death in China. Although multiple treatment modalities including surgery, radiotherapy and chemotherapy have been developed, the prognosis of advanced CRC still remains poor. While around 30% of resectable advanced CRC could be cured. This study is designed to compare perioperative FOLFIRI versus adjuvant FOLFIRI in resectable advanced CRC who exposed to oxaliplatin in open-label, phase III mode.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The 6th Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Sub-Investigator:
          • Jian Xiao, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:18-80
  • ECOG score: 0 or 1
  • Histological confirmed of Colorectal Adenocarcinoma
  • History of exposure to oxaliplatin
  • With local recurrent or metastatic focus
  • Tumor resectable confirmed by at less 3 hepatobiliary surgeon
  • Informed content acquired

Exclusion Criteria:

  • History of Exposure to Irinotecan
  • Received surgery in recently 4 weeks or did not recover from surgery
  • Other history of cancer in recent 5 years
  • Fluorouracil allergy or dihydropyrimidine dehydrogenase defect
  • Women with potential pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant therapy arm
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
Drug: 5-fluorouracil
Drug: Irinotecan
Radiation: Local radiotherapy
Procedure: R0 resection
Active Comparator: Adjuvant therapy arm
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
Drug: 5-fluorouracil
Drug: Irinotecan
Radiation: Local radiotherapy
Procedure: R0 resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progress Free Survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 Years
3 Years
R0 Resection Rate
Time Frame: 6 Month
6 Month
Treatment RelatedToxicity
Time Frame: 3 Year
Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
3 Year
Life Quality
Time Frame: 3 Years
EORTC QoL Questionaires
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Principal Investigator: Ping Lan, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

June 5, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAH 5010 CRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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