Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

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: NCT02557490
Recruitment Status : Unknown
Verified July 2015 by Zhu Xu, Beijing Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Zhu Xu, Beijing Cancer Hospital

Brief Summary:
The purpose of this study was a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion

Condition or disease Intervention/treatment Phase
Colon Cancer Liver Metastasis Drug: oxaliplatin and raltitrexed Phase 4

Detailed Description:
Colorectal cancer is one of the most common malignancies, with 1 million new cases and half a million deaths each year worldwide. The development of metastases is the main cause of death. Liver metastases are diagnosed in 10-25% of patients at the time of resection of their primary colorectal tumor and, eventually, up to 70% of patients with colorectal cancer develop liver metastases.Oxaliplatin and raltitrexed were used for the treatment of colorectal cancer with liver metastases. We aimed to perform a randomized controlled trial to compare the effect of oxaliplatin and raltitrexed treatment of colorectal cancer with liver metastases by TACE hepatic artery infusion.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Oxaliplatin by TACE
Oxaliplatin for the therapy of Colorectal Cancer With Liver Metastases by TACE.No interventions was raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.
Drug: oxaliplatin and raltitrexed

TACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement.

Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B)


No Intervention: Raltitrexed by TACE
Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.



Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: three years ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: three years ]


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 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. With written informed consent
  2. Age ranged from 18 to 80 years, both men and women
  3. Confirmed by pathology or clinical diagnosis of unresectable colorectal cancer with liver metastases patients(including the primary tumor and liver in patients with brain metastases except outside of metastasis in patients with unresectable)
  4. Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
  5. Never received TACE treatment
  6. (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
  7. ECOG PS score of ≤2
  8. expected survival time ≥12 weeks
  9. The test results before 7 days entered the group must meet the following requirements:

    • Hemoglobin ≥ 90 g / L
    • Absolute neutrophil count (ANC)> 1,500 / mm3
    • Platelet count ≥ 80x109 / L
    • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal (UNL)
    • Total bilirubin <3UNL
    • Serum creatinine <1.5 UNL
    • PT or INR, PPT <1.5 UNL (for patients undergoing warfarin or heparin anticoagulant therapy, if there is no evidence that there is an abnormality of the above parameters, you can enter the group, but must be closely monitored to detect at least once a week until the INR stable)

Exclusion criteria

  1. Specific circumstances of patients not suitable for TACE therapy / chemotherapy
  2. Hepatic decompensation, or the presence of hepatic encephalopathy
  3. Before entering the study with gastrointestinal bleeding within 30 days
  4. Presence of brain metastasis
  5. Pregnant or lactating women
  6. Active bleeding or sepsis
  7. History of heart disease:

    • NYHA two or more of congestive heart failure, symptomatic coronary artery disease
    • Need to use β-blockers or digoxin medication other than arrhythmias
  8. Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
  9. Not cure severe trauma, acute or incurable ulcer, or three months fracture
  10. The researchers believe their poor compliance
  11. Exist once or primary lesion or histologically different tumors and colorectal cancer, except: head and neck carcinoma in situ, cured basal cell carcinoma, superficial bladder cancer (Ta, Tis, T1), and the group 3 years ago, it has been cured of cancer
  12. HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
  13. Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
  14. Need drug therapy epilepsy (such as steroids or antiepileptic drugs
  15. Chemotherapy contraindications exist
  16. Any instability or likely to endanger the patient in this study the safety and compliance of the case

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): NCT02557490


Locations
Layout table for location information
China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Zhu Xu, Master    0086-10-88195476    zhux387@263.net   
Principal Investigator: Zhu Xu, Master         
Sponsors and Collaborators
Zhu Xu

Layout table for additonal information
Responsible Party: Zhu Xu, Interventional Therapy Department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT02557490     History of Changes
Other Study ID Numbers: 2014YJZ16
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: July 2015
Keywords provided by Zhu Xu, Beijing Cancer Hospital:
TACE; hepatic artery infusion; oxaliplatin; raltitrexed
Additional relevant MeSH terms:
Layout table for MeSH terms
Oxaliplatin
Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Raltitrexed
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors