Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

NCT ID: NCT02557490

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Colon Cancer Liver Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

oxaliplatin and raltitrexed

Intervention Type: DRUG

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)

Raltitrexed by TACE

Raltitrexed for the therapy of Colorectal Cancer With Liver Metastases by TACE.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhu Xu

OTHER

Sponsor Role: lead

Responsible Party

Zhu Xu

Interventional Therapy Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhu Xu, Master

Role: primary

zhux387@263.net

0086-10-88195476

References

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.

Reference Type: DERIVED

PMID: 36212504 (View on PubMed)

Other Identifiers

2014YJZ16

Identifier Type: -

Identifier Source: org_study_id