Oxaliplatin and Raltitrexed Treatment of Colorectal Cancer With Liver Metastases

NCT02557490 | Unknown Phase 4

• 1 other identifier: 2014YJZ16
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Cancer Liver Metastasis

Keywords

TACE; hepatic artery infusion; oxaliplatin; raltitrexed

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  three years

Secondary Outcomes (1)

• overall survival (OS)

  three years

Study Arms (2)

Oxaliplatin by TACE

EXPERIMENTAL

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

Raltitrexed by TACE

NO INTERVENTION

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

Interventions

oxaliplatin and raltitrexed 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)

Oxaliplatin by TACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhu Xu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 36212504 DERIVED

MeSH Terms

Interventions

Oxaliplatin; raltitrexed

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Interventional Therapy Department

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: September 23, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 23, 2015

Record last verified: 2015-07

Locations

CN (1)