Safety of TACE With Oxaliplatin, Irinotecan and Raltitrexed for Refractory Colorectal Cancer Liver Metastasis

NCT02631564 | Unknown DMC

• 1 other identifier: Ral-1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe whether hepatic infusion by oxaliplatin, irinotecan and raltitrexed with or without embolization by lipiodol or microspheres are effective in the treatment of refratory liver metastasis from colorectal cancer.

Conditions

Colon Cancer Liver Metastasis

Keywords

mCRC;TACE;hepatic infusion;raltitrexed

Outcome Measures

Primary Outcomes (1)

• number of adverse events

  6 months

Secondary Outcomes (2)

• Overall survival

  2 years

• Time to progression

  one year

Eligibility Criteria

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

Study Population

Refractory liver metastasis from colon and rectal cancer

You may qualify if:

• Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and for which standard curative measures do not exist
• Patients must have received prior irinotecan-based treatment for their disease and had documented progression by RECIST criteria; patients must also have received prior fluoropyrimidine and oxaliplatin-based therapy
• Liver disease must not be amenable to potentially curative surgical resection
• Patients must have liver-only or liver-predominant disease to be eligible for this study; hepatic disease must be dominant, but patients are allowed to have extrahepatic disease provided it is not judged likely to be life threatening within 3 months
• Patients must have a patent portal vein as documented by CT, MRI, or ultrasound
• Prior radiation therapy is allowed but must have been completed \>= 4 weeks prior to study entry; patients with history of prior radiation to the liver including radio-labeled microspheres cannot take part in this study
• Eastern Cooperative Oncology Group performance status 0-1
• Previous surgery or RFA to the liver is allowed; patients with history of chemoembolization or radio-labeled microspheres are excluded
• Life expectancy of \>= 12 weeks
• Leukocytes \>= 3,000/uL
• Absolute neutrophil count \>= 1,500/uL
• Platelets \>= 100,000/uL
• Total bilirubin =\< ULN
• AST(SGOT)/ALT(SGPT)/Alkaline Phosphatase =\< 2.5 X institutional ULN
• Creatinine \< 2.0 mg/dL

You may not qualify if:

• Hepatic decompensation, or the presence of hepatic encephalopathy Before entering the study with gastrointestinal bleeding within 30 days
• Pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including death from the therapeutic agents
• Patients with known brain metastases are excluded from this study because of their poor prognosis and frequent development of progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events
• As patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, known HIV-positive patients and those with known hepatitis B or C are excluded from the study Uncontrolled intercurrent illness including, but not limited to, ongoing or active bacterial infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients with clinically evident ascites requiring medical management or paracentesis, or Childs-Pugh score B/C are not eligible
• Patients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma of the skin
• Patient with significant cardiac, renal or hematologic or pulmonary dysfunction
• Patients with previous chemoembolization to liver metastases Patients may not receive any other anticancer therapy while on study, including immunotherapy; patients may not receive any other clinical investigational drug

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Officials

• Bo Zhou, M.D,Ph.D

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Zhou, M.D, Ph.D

CONTACT

8621-18616880602; bonheurzhou@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CN (1)