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FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

NCT ID: NCT01566942

Last Updated: 2012-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-06-30

Brief Summary

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

Detailed Description

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Conditions

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Colorectal Cancer

Keywords

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FOLFIRI FOLFOX adjuvant chemotherapy advanced colorectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOX

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

Group Type ACTIVE_COMPARATOR

Oxaliplatin

Intervention Type DRUG

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

FOLFIRI

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

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

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

Interventions

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Oxaliplatin

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

Intervention Type DRUG

Irinotecan

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yulong He

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YULONG HE, PhD

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Facility Contacts

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JIANJUN PENG, PhD

Role: primary

Other Identifiers

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2011-170

Identifier Type: -

Identifier Source: org_study_id