Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases (TACE)

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: NCT01959061
Recruitment Status : Unknown
Verified March 2017 by Nanjing Chia-tai Tianqing Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : October 9, 2013
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Nanjing Chia-tai Tianqing Pharmaceutical

Tracking Information
First Submitted Date  ICMJE September 18, 2013
First Posted Date  ICMJE October 9, 2013
Last Update Posted Date March 13, 2017
Actual Study Start Date  ICMJE September 2013
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2017)
Progression-free survivial [ Time Frame: 8 months after last patient randomized ]
From date of randomization until date of first documented PD, date of death
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2013)
  • lesion [ Time Frame: 4 weeks ]
    change of the lesion size in liver
  • ECOG [ Time Frame: 4 weeks ]
    change of ECOG Performance Status
Change History Complete list of historical versions of study NCT01959061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases
Official Title  ICMJE Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
Brief Summary To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer
Detailed Description evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer Metastatic
Intervention  ICMJE
  • Drug: Raltitrexed
    4mg, every 4 weeks,transhepatic arterial infusion
  • Drug: Oxaliplatin
    100~150mg, every 4 weeks, transhepatic arterial infusion
  • Drug: lipiodol
    5-20ml, every 4 weeks, hepatic artery embolization
Study Arms  ICMJE Experimental: Raltitrexed and Oxaliplatin
Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.
Interventions:
  • Drug: Raltitrexed
  • Drug: Oxaliplatin
  • Drug: lipiodol
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: October 7, 2013)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically confirmed colorectal adenocarcinoma
  2. Disease limited to the liver Unresectable disease by surgery or other local therapies
  3. Age >18 years
  4. ECOG performance status 0-2,Child pugh A or B
  5. Expected survival ≥ 3 months
  6. Adequate hematological, hepatic, and renal function

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Patients with severe organ dysfunction or failure
  3. With severe cardiovascular disease, or mental
  4. Extraliver metastases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 NCT01959061
Other Study ID Numbers  ICMJE NJCTTQ-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nanjing Chia-tai Tianqing Pharmaceutical
Study Sponsor  ICMJE Nanjing Chia-tai Tianqing Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianhua Wang Fudan University
PRS Account Nanjing Chia-tai Tianqing Pharmaceutical
Verification Date March 2017

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