Irinotecan Drug-eluting Bead Liver Embolisation Registry

NCT03697044 | Unknown DMC

• 1 other identifier: Christie NHS
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The purpose of this study is: to assess and define the current practice of the delivery of irinotecan loaded drug eluting beads in the treatment of liver metastases from colorectal cancer; to correlate how the delivery of this drug compares to worldwide/European guidelines, and to determine which individual variations in delivery may be associated with an increased complication profile or better outcome. The aim of the study is to:

1. 1.Prospectively evaluate the number of centres providing DEBIRI
2. 2.To determine the number of patients being treated nationally per year
3. 3.To evaluate individual variations in practice with respect to number of treatments, method of pain control, side effect profile, and complication profile.
4. 4.To collect patient specific data subsets to allow correlation and causal associations between these individual variations, and relate these to efficacy and survival during the study period.

Conditions

Colorectal Cancer Metastatic; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Time to Hepatic Progression (TtHP)

  Progression as measured by RECIST 1.1 criteria up to 2 years after treatment

  2 years after treatment

Secondary Outcomes (3)

• Overall survival (OS)

  2 years after treatment

• Adverse events

  4 months after treatment

• Quality of Life post DEBIRI delivery

  4 months after treatment

Interventions

Irinotecan Drug-Eluting-Bead Trans Arterial ChemoEmbolisation PROCEDURE

Patient Registry to assess the delivery of Irinotecan loaded drug eluting beads for the treatment of colorectal liver cancer metastases.

Also known as: DEBIRI, DEB TACE

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

Patients with histologically proven colorectal carcinoma with synchronous or metachronous hepatic metastases selected for treatment with Irinotecan Drug-eluting beads.

You may qualify if:

• Any race or sex
• Age 18-80.
• Histological diagnosis of Colorectal malignancy.
• Histological or radiological evidence of liver metastases from Colorectal Primary.
• Not suitable for surgical resection or ablation with curative intent.
• Metastatic liver burden occupying less than 50% of liver volume
• Liver dominant disease (defined as 80% or more of the overall whole body tumour burden confined to the liver).
• At least 1 measurable liver metastasis measuring over 1cm in size (RECIST 1.1 criteria to be applied).
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1. ECOG 2 may occasionally be permissible on an individual patient by patient basis in line with local guidelines.
• Life expectancy 3+ months.
• Lack of pregnancy with ongoing use of acceptable contraceptive(in premenopausal women.
• Patent main portal vein.
• Adequate haematologic function as evidenced by: Haemoglobin of at least 8g/dl, platelets of at least 50 x 109/l, and International Normalised Ratio (INR) of under 1.5.
• Adequate liver function as evidence by a bilirubin level of less than twice the upper limit of normal.
• Deemed to be a suitable patient for DEBIRI treatment by MDT consensus.

You may not qualify if:

• Previous or concurrent non-colorectal malignancy.
• No contraindication to Irinotecan administration.
• Uncorrectable clotting abnormality
• Documented allergy to contrast media that cannot be managed with standard care(steroids and antihistamines)
• Family, psychological, social or geographical circumstances preventing the patient from undergoing follow-up or from complying with protocol procedures

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie Hospital NHS Foundation Trust

Manchester, M204BX, United Kingdom

Location

Central Study Contacts

Damian Mullan, MD

CONTACT

00441614463000; damian.mullan@christie.nhs.uk

Jon Bell, MD

CONTACT

00441614463000; jon.bell@christie.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Radiologist

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

GB (1)