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FOLFIRI or mFOLFOX6 in Adjuvant Chemotherapy in Advanced Colorectal Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Yulong He, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566942
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Yulong He, Sun Yat-sen University
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • disease-free survival(DFS) [ Time Frame: 3-year disease-free survival rate ]
    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 ]
    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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 26, 2012
First Posted: March 30, 2012
Last Update Posted: March 30, 2012
Last Verified: March 2012

Keywords provided by Yulong He, 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
Oxaliplatin
Irinotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action