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

Primary Purpose

Colorectal Neoplasms, Effects of Chemotherapy, Surgery

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Irinotecan
5-fluorouracil
Local radiotherapy
R0 resection
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The 6th Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant therapy arm

Adjuvant therapy arm

Arm Description

FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles

Surgery -> FOLFIRI * 12 cycles +/- radiotherapy

Outcomes

Primary Outcome Measures

Progress Free Survival

Secondary Outcome Measures

Overall Survival
R0 Resection Rate
Treatment RelatedToxicity
Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
Life Quality
EORTC QoL Questionaires

Full Information

First Posted
March 7, 2014
Last Updated
June 4, 2019
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02087475
Brief Title
Perioperative FOLFIRI VS Adjuvant FOLFIRI in Resectable Advanced CRC Failed to Oxaliplatin
Official Title
Randomized Open-label Phase III Study Comparing Perioperative FOLFIRI Versus Adjuvant FOLFIRI in Resectable Advanced Colorectal Cancer Failed to Oxaliplatin-containing Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Effects of Chemotherapy, Surgery, Metastasis, Local Neoplasm Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant therapy arm
Arm Type
Experimental
Arm Description
FOLFIRI * 6 cycles +/- radiotherapy -> surgery -> FOLFIRI * 6 cycles
Arm Title
Adjuvant therapy arm
Arm Type
Active Comparator
Arm Description
Surgery -> FOLFIRI * 12 cycles +/- radiotherapy
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Intervention Type
Radiation
Intervention Name(s)
Local radiotherapy
Intervention Type
Procedure
Intervention Name(s)
R0 resection
Primary Outcome Measure Information:
Title
Progress Free Survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 Years
Title
R0 Resection Rate
Time Frame
6 Month
Title
Treatment RelatedToxicity
Description
Adverse events grade that greater than 3 is considered secondary endpoint, according to the Common Terminology Criteria for Adverse Events Version 3.0.
Time Frame
3 Year
Title
Life Quality
Description
EORTC QoL Questionaires
Time Frame
3 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Xiao, MD
Phone
+8613711114566
Email
xiao_jian@139.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Lan, MD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 6th Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD
Phone
+8613711114566
Email
xiao_jian@139.com
First Name & Middle Initial & Last Name & Degree
Jian Xiao, MD

12. IPD Sharing Statement

Learn more about this trial

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

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