FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Oxaliplatin; Drug: Irinotecan

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FOLFOX; In this group, the patients will receive the adjuvant chemotherapy with mFOLFOX6.	Drug: 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
Experimental: FOLFIRI; in this arm, patients will receive adjuvant chemotherapy with FOLFIRI regimen for about 8 cycles	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival(OS)	The 5-year survival rate will be the secondary end point. The investigator will follow up the patients and campare the difference of 5-year-OS between the two groups.	5-year survival

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: YULONG HE, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): May 1, 2014
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 26, 2012
• First Submitted That Met QC Criteria: March 27, 2012
• First Posted (Estimate): March 30, 2012

Study Record Updates

• Last Update Posted (Estimate): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 27, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: FOLFOX; adjuvant chemotherapy; advanced colorectal cancer; FOLFIRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Oxaliplatin; Irinotecan
• Other Study ID Numbers: 2011-170