Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

• Sponsor: Zhu Xu (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02557490
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 2.9

Study Details

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

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Jan 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) [three years]

Secondary Outcome Measures

1. overall survival (OS) [three years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Despite treatment, still systolic blood pressure> 150 mmHg or diastolic blood pressure> 90 mmHg hypertension

2. Not cure severe trauma, acute or incurable ulcer, or three months fracture

3. The researchers believe their poor compliance

4. 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

5. HIV infection or the presence of AIDS-related illness, or severe acute and chronic diseases

6. Drug abuse, or suffering that could interfere with study compliance and other psychological or psychiatric disorders

7. Need drug therapy epilepsy (such as steroids or antiepileptic drugs

8. Chemotherapy contraindications exist

9. Any instability or likely to endanger the patient in this study the safety and compliance of the case

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Cancer Hospital	Beijing	Beijing	China	100142

Sponsors and Collaborators

• Zhu Xu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhu Xu, Interventional Therapy Department, Peking University Cancer Hospital & Institute
• ClinicalTrials.gov Identifier: NCT02557490
• Other Study ID Numbers: 2014YJZ16
• First Posted: Sep 23, 2015
• Last Update Posted: Sep 23, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Zhu Xu, Interventional Therapy Department, Peking University Cancer Hospital & Institute: TACE; hepatic artery infusion; oxaliplatin; raltitrexed
• Additional relevant MeSH terms: Neoplasm Metastasis; Liver Neoplasms; Oxaliplatin; Raltitrexed

Study Results

No Results Posted as of Sep 23, 2015