NCT01566942

Brief Summary

the aim of this study is to observe the effect of irinotecan-based regimen in patients with advanced colorectal cancer.

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
200

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2012

Typical duration for phase_3 colorectal-cancer

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

First Submitted

Initial submission to the registry

March 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 30, 2012

Status Verified

March 1, 2012

Enrollment Period

1.9 years

First QC Date

March 26, 2012

Last Update Submit

March 27, 2012

Conditions

Colorectal Cancer

Keywords

FOLFIRIFOLFOXadjuvant chemotherapyadvanced colorectal cancer

Outcome Measures

Primary Outcomes (1)

  • disease-free survival（DFS）

    The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.

    3-year disease-free survival rate

Secondary Outcomes (1)

  • overall survival(OS)

    5-year survival

Study Arms (2)

FOLFOX

ACTIVE COMPARATOR

In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.

Drug: Oxaliplatin

FOLFIRI

EXPERIMENTAL

in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles

Drug: Irinotecan

Interventions

OxaliplatinDRUG

In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks

FOLFOX
IrinotecanDRUG

In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks

FOLFIRI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed adenocarcinoma in colorectal cancer
  • clinical stage Ⅲ or Ⅳa(with potential radical resective metastatic lesions),≥ 12 lymph nodes examined
  • no cancer cells were found in ascites
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0-2
  • male or female, between 18 and 75 years old
  • adequate hematologic, hepatic and renal functions
  • without severe heart disease in the last 6 months before enrolled. If with hypertension or coronary artery disease, it can be controlled
  • not enrolled into others clinical trial during this study
  • all patients should sign the informed consent

You may not qualify if:

  • can not be tolerated operation
  • receiving others therapy(including Traditional Chinese herbs)for this disease, can not obey the investigator during the study
  • can not be tolerated the adverse effect of drugs in these regimens
  • major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery
  • metastatic disease more than one organ
  • pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

OxaliplatinIrinotecan

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • YULONG HE, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

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
GI Surgery, the First Affiliated Hospital, Sun Yat-sen University

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 30, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2014

Study Completion

June 1, 2017

Last Updated

March 30, 2012

Record last verified: 2012-03

Locations

CN(1)