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Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer

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.
 
ClinicalTrials.gov Identifier: NCT02688023
Recruitment Status : Unknown
Verified February 2016 by Jing Huang, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Collaborator:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Jing Huang, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE February 11, 2016
First Posted Date  ICMJE February 23, 2016
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
3-year disease-free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • objective response rate [ Time Frame: 2 years ]
  • Surgical complete resection rate (R0) [ Time Frame: 2 years ]
  • overall survival [ Time Frame: 6 years ]
  • Number of participants with adverse events that are related to treatment [ Time Frame: 2 years ]
  • Number of participants with surgery complications [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
Official Title  ICMJE A Pilot Phase II Study of Triplet Chemotherapy Regimen in Neoadjuvant Chemotherapy of Patients With Resectable Colorectal Cancer
Brief Summary Colorectal cancer is an aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the feasibility, safety and efficacy of neoadjuvant oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.
Detailed Description This is a single arm, phase 2 study of neoadjuvant triplet chemotherapy regimen of oxaliplatin, irinotecan combined with 5-fluorouraci/leucovorin or S-1 or capecitabine in patients with resectable colorectal cancer.Fifty patients will be enrolled in this trial. The primary objective of this study is to determine the 3-year disease-free survival of the patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.
Study Arms  ICMJE Experimental: single-arm Irinotecan-Oxaliplatin-5-Fluorouracil/leucovorin
Irinotecan,oxaliplatin and 5-fluorouracil/leucovorin(5-fluorouracil/leucovorin can be substituted with Capecitabine or S-1)
Intervention: Drug: oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically verified colorectal cancer
  • clinical stage T4N0-2M0、cT1-3N2M0 or M1(liver metastases only)
  • age: 18-70 years
  • ECOG 0-2
  • adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease)
  • no prior cancer and/or chemotherapy
  • signed informed consent

Exclusion Criteria:

  • patients with a history of prior malignancy
  • pregnant or lactating patients
  • known or suspected brain metastasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02688023
Other Study ID Numbers  ICMJE CH-GI-052
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jing Huang, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators  ICMJE
Principal Investigator: Jing Huang, M.D. Cancer Hospital, CAMS
PRS Account Chinese Academy of Medical Sciences
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP