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

Brief Summary:
To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Raltitrexed Drug: Oxaliplatin Drug: lipiodol Phase 4

Detailed Description:
evaluate the efficacy and safety of Raltitrexed and oxaliplatin and lipiodol transcatheter arthrial chemoembolization for in refractory colorectal carcinoma with liver metastases.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Raltitrexed and Oxaliplatin and Lipiodol Transcatheter Arterial Chemoembolization for Advanced Colorectal Cancer
Actual Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Progression-free survivial [ Time Frame: 8 months after last patient randomized ]
    From date of randomization until date of first documented PD, date of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01959061


Contacts
Layout table for location contacts
Contact: Jianhua Wang 021-64041990 wang.jianhua@zs-hospital.sh.cn

Locations
Layout table for location information
China, Shanghai
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 2000032
Contact: Jianhua Wang         
Sponsors and Collaborators
Nanjing Chia-tai Tianqing Pharmaceutical
Investigators
Layout table for investigator information
Principal Investigator: Jianhua Wang Fudan University

Layout table for additonal information
Responsible Party: Nanjing Chia-tai Tianqing Pharmaceutical
ClinicalTrials.gov Identifier: NCT01959061     History of Changes
Other Study ID Numbers: NJCTTQ-01
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nanjing Chia-tai Tianqing Pharmaceutical:
Advanced colorectal cancer of liver metastatic

Additional relevant MeSH terms:
Layout table for 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
Ethiodized Oil
Raltitrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors