Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

Phase 4

• Conditions: Colon Cancer Liver Metastasis
• Interventions: Drug: oxaliplatin and raltitrexed

• Registration Number: NCT02557490
• Lead Sponsor: Zhu Xu

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.

Study Timeline

• Study Start: 2015-01
• Status Verified: 2015-07
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Study First Posted: 2015-09-23
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxaliplatin by TACE	oxaliplatin and raltitrexed	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	three years

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	three years

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China