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FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

This study is not yet open for participant recruitment.
Verified March 2012 by Sun Yat-sen University
Sponsor:
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Yulong He, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01566942
First received: March 26, 2012
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
 Drug: Oxaliplatin
Drug: Irinotecan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: FOLFIRI or mFOLFOX6 as Adjuvant Chemotherapy Regiment After Neo-adjuvant Chemotherapy With FOLFIRI in Patients With Advanced Colorectal Cancer: a Randomized, Multicenter Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • disease-free survival（DFS） [ Time Frame: 3-year disease-free survival rate ] [ Designated as safety issue: Yes ]
    The investigator will follow up all the enrolled patients. The difference of 3-year-DFS between two groups will be compared.


Secondary Outcome Measures:
  • overall survival(OS) [ Time Frame: 5-year survival ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566942

Locations
China, Guangdong
the first affiliated hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: JIANJUN PENG, PhD     86-20-87332200 ext 8211     aidigua@hotmail.com    
Sponsors and Collaborators
Sun Yat-sen University
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Chair: YULONG HE, PhD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Yulong He, GI Surgery, the First Affiliated Hospital, Sun Yat-sen University, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01566942     History of Changes
Other Study ID Numbers: 2011-170
Study First Received: March 26, 2012
Last Updated: March 27, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
FOLFIRI
FOLFOX
adjuvant chemotherapy
advanced colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adjuvants, Immunologic
Oxaliplatin
 Irinotecan
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013