- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631564
Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis
December 14, 2015 updated by: Bo Zhou, Fudan University
An Observational Study of TACE Hepatic Arterial Infusion of Oxaliplatin, Irinotecan and Raltitrexed Treatment for Refractory Liver Metastasis From Colorectal Cancer
The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.
Study Overview
Status
Unknown
Conditions
Detailed Description
Colorectal cancer is one of most popular cancer worldwide.
Patients with liver metastasis have poor prognosis except for curative resection.
Chemotherapy combined biologic agents have improved mCRC median progress free survival and median overall surivival, but it is difficult to deal with liver lesions after FOLFOX and FOLFIRI treatments failed.
We aim to observe the safety and efficacy of hepatic infusion and embolization of oxaliplatin, irinotecan and raltitrexed treatment for refratory liver metastasis from colorectal cancer.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Zhongshan Hospital
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Contact:
- Bo Zhou, M.D,Ph.D
- Phone Number: 8621-18616880602
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Refractory liver metastasis from colon and rectal cancer
Description
Inclusion Criteria:
- Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
- Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
- Liver disease must not be amenable to potentially curative surgical resection
- Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
- Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
- Prior radiation therapy is allowed but must have been completed >= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
- Eastern Cooperative Oncology Group performance status 0-1
- Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
- Life expectancy of >= 12 weeks
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- Total bilirubin =< ULN
- AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =< 2.5 X institutional ULN
- Creatinine < 2.0 mg/dL
- PT/PTT < 1.5 X ULN
- Women of childbearing potential (WOCBP) and sexually active males must agree to use an accepted and effective method of contraception prior to study entry and for the duration of the study; WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal; even women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) should be considered to be of child bearing potential
- Patients must demonstrate ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days
- Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
- Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
- As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
- Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
- Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
- Patients with previous chemoembolization to liver metastases Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of adverse events
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 2 years
|
2 years
|
Time to progression
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Zhou, M.D,Ph.D, Shanghai Zhongshan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
June 1, 2017
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
December 14, 2015
First Submitted That Met QC Criteria
December 14, 2015
First Posted (Estimate)
December 16, 2015
Study Record Updates
Last Update Posted (Estimate)
December 16, 2015
Last Update Submitted That Met QC Criteria
December 14, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ral-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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