Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

Colon Cancer Liver Metastasis Clinical Trial

Official title:

A Randomized Controlled Trial of TACE Hepatic Artery Infusion of Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02557490
• Other study ID #: 2014YJZ16
• Status: Recruiting
• Phase: Phase 4
• First received: September 22, 2015
• Last updated: September 22, 2015
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Beijing Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer Liver Metastasis
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

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)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Zhu Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)		three years	Yes
Secondary	overall survival (OS)		three years	Yes