Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
Primary Purpose
Colon Cancer Liver Metastasis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
oxaliplatin and raltitrexed
Sponsored by
About this trial
This is an interventional treatment trial for Colon Cancer Liver Metastasis focused on measuring TACE; hepatic artery infusion; oxaliplatin; raltitrexed
Eligibility Criteria
Inclusion Criteria:
- With written informed consent
- Age ranged from 18 to 80 years, both men and women
- 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)
- Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
- Never received TACE treatment
- (M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
- ECOG PS score of ≤2
- expected survival time ≥12 weeks
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
- Specific circumstances of patients not suitable for TACE therapy / chemotherapy
- Hepatic decompensation, or the presence of hepatic encephalopathy
- Before entering the study with gastrointestinal bleeding within 30 days
- Presence of brain metastasis
- Pregnant or lactating women
- Active bleeding or sepsis
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
- Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
- Not cure severe trauma, acute or incurable ulcer, or three months fracture
- The researchers believe their poor compliance
- 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
- HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
- Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
- Need drug therapy epilepsy (such as steroids or antiepileptic drugs
- Chemotherapy contraindications exist
- Any instability or likely to endanger the patient in this study the safety and compliance of the case
Sites / Locations
- Beijing Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oxaliplatin by TACE
Raltitrexed by TACE
Arm Description
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.
Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Secondary Outcome Measures
overall survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02557490
Brief Title
Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
Official Title
A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhu Xu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Liver Metastasis
Keywords
TACE; hepatic artery infusion; oxaliplatin; raltitrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oxaliplatin by TACE
Arm Type
Experimental
Arm Description
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.
Arm Title
Raltitrexed by TACE
Arm Type
No Intervention
Arm Description
Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.
Intervention Type
Drug
Intervention Name(s)
oxaliplatin and raltitrexed
Intervention Description
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)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
three years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With written informed consent
Age ranged from 18 to 80 years, both men and women
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)
Progress systemic chemotherapy or who can not tolerate chemotherapy, or who refuse chemotherapy
Never received TACE treatment
(M) RECIST 1.0 criteria measurable liver lesions at several ≥2, each lesion diameter ≥3 cm long and ≤20cm,
ECOG PS score of ≤2
expected survival time ≥12 weeks
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
Specific circumstances of patients not suitable for TACE therapy / chemotherapy
Hepatic decompensation, or the presence of hepatic encephalopathy
Before entering the study with gastrointestinal bleeding within 30 days
Presence of brain metastasis
Pregnant or lactating women
Active bleeding or sepsis
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
Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension
Not cure severe trauma, acute or incurable ulcer, or three months fracture
The researchers believe their poor compliance
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
HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases
Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders
Need drug therapy epilepsy (such as steroids or antiepileptic drugs
Chemotherapy contraindications exist
Any instability or likely to endanger the patient in this study the safety and compliance of the case
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Xu, Master
Phone
0086-10-88195476
Email
zhux387@263.net
First Name & Middle Initial & Last Name & Degree
Zhu Xu, Master
12. IPD Sharing Statement
Citations:
PubMed Identifier
36212504
Citation
Feng AW, Guo JH, Gao S, Kou FX, Liu SX, Liu P, Chen H, Wang XD, Xu HF, Cao G, Zhu X. A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases. Front Oncol. 2022 Sep 21;12:913017. doi: 10.3389/fonc.2022.913017. eCollection 2022.
Results Reference
derived
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Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases
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