NCT02087475

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

10.9 years

First QC Date

March 7, 2014

Last Update Submit

June 4, 2019

Conditions

Colorectal NeoplasmsEffects of ChemotherapySurgeryMetastasisLocal Neoplasm Recurrence

Outcome Measures

Primary Outcomes (1)

  • Progress Free Survival

    3 years

Secondary Outcomes (4)

  • Overall Survival

    3 Years

  • R0 Resection Rate

    6 Month

  • Treatment RelatedToxicity

    3 Year

  • Life Quality

    3 Years

Study Arms (2)

Neoadjuvant therapy arm

EXPERIMENTAL

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

Drug: IrinotecanDrug: 5-fluorouracilRadiation: Local radiotherapyProcedure: R0 resection

Adjuvant therapy arm

ACTIVE COMPARATOR

Surgery -\> FOLFIRI \* 12 cycles +/- radiotherapy

Drug: IrinotecanDrug: 5-fluorouracilRadiation: Local radiotherapyProcedure: R0 resection

Interventions

IrinotecanDRUG
Adjuvant therapy armNeoadjuvant therapy arm
5-fluorouracilDRUG
Adjuvant therapy armNeoadjuvant therapy arm
Local radiotherapyRADIATION
Adjuvant therapy armNeoadjuvant therapy arm
R0 resectionPROCEDURE
Adjuvant therapy armNeoadjuvant therapy arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 6th Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisNeoplasm Recurrence, Local

Interventions

IrinotecanFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Ping Lan, MD

    Sixth Affiliated Hospital, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xiao, MD

CONTACT

+8613711114566xiao_jian@139.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

January 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2024

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

CN(1)