ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611001273976

Ethics application status

Approved

Date submitted

9/12/2011

Date registered

12/12/2011

Date last updated

28/07/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Assessment of the Safety and Efficacy of Intra-Arterial Liver Isolation Chemotherapy Using an Implantable Vascular Access System

Scientific title

Treating patients with colorectal liver metastases or hepatocellular carcinoma with intra-arterial liver isolation chemotherapy delivered through an implantable vascular access system and to determine its feasibility, safety and efficacy.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1126-1877

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

1. Secondary hepatic metastases from colorectal cancer
2. Hepatocellular carcinoma

Condition category

Condition code

Cancer

Liver

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

SCREENING & WORK UP: The patient is screened by the trial staff and a comprehensive patient history is recorded. Baseline blood tests and a CTA scan is carried out to determine patient suitability. A baseline PET-CT scan is also performed to determine treatment lesions. A Quality of Life (QOL) Survey will be filled in by the patient at this time also.

DEVICE IMPLANTATION PROCEDURE: The procedure involves the surgical implantation under general anaesthetic of a large bore temporary access port (a peripheral access sytem) in either the common femoral artery or the subclavian artery. The device is implanted by anastomosing the ePTFE graft skirt of the device onto the patient's common femoral artery and tunnelling the tubing of the device through the patient's subcutaneous tissue in the upper thigh/pectoralis and out through the skin. The implantation procedure can take between 1-3 hours and the patient can be discharged after recovery.

CHEMOTHERAPY INFUSION PROCEDURE: During the chemotherapy infusion sessions the patient will be ventilated with positive end-expiratory pressure (PEEP) whilst under general anesthesia. Depending on the specific patient anatomy up to 4 catheters will be used to selectively cannulate and obstruct the target visceral vessels. Once the flow to the liver is isolated, a microcatheter will be used via the coeliac trunc to superselectively target a pre-determined liver lesion and subsequently deliver chemotherapy locally for 20-30 minutes. All catheters are removed after the infusion and the patient discharged after recovery. The procedure is expected to take between 60-200 minutes. Depending on the patient response, the patient will be infused 3-8 times over the 30 day course.

DEVICE EXPLANTATION PROCEDURE: After the final chemotherapy infusion, and on the same day, the patient undergoes an explantation procedure where the implanted access device is removed and the vessel sutured, either with or without a patch angioplasty. This procedure takes approximately 1-2 hours and the patient is discharged after recovery.

FOLLOW UP PROCEDURE: The trial staff will follow up on the progress of the patient at 1 week, 1 month, 3 months, and 6 months from the date of the explantation procedure. A PET-CT scan and a QOL Survey will be carried out during the 1 month follow up period.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

This is a feasibility and safety/efficacy study as there is no comparator/control treatment.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To determine the feasibility of the implantable access port in its ability to facilitate the administration of chemotherapy via intra-arterial liver isolation. Outcome is assessed through evaluation of all the operative reports of the standardised chemotherapy infusion sessions carried out.

Timepoint [1]

At every chemotherapy infusion session

Primary outcome [2]

To determine the safety and efficacy of intra-arterial liver isolation chemotherapy using the implantable vascular access system. Outcome is assessed through monitoring serious adverse events and adverse events such as significant infection, haematoma/haemorrhage, septicaemia, or significant thrombosis.

Timepoint [2]

From implantation to 3 months post-explantation

Secondary outcome [1]

To increase the overall survival rate of patients. Assessed by survivorship through post-treatment follow ups.

Timepoint [1]

Follow-ups beyond 3 month post-explantation

Secondary outcome [2]

To increase the patient's response rate to the chemotherapy. Assessed by resectability of tumour post-treatment and changes in tumour size.

Timepoint [2]

Baseline PET-CT and ultrasound of the liver and at 1 month post-explantation

Secondary outcome [3]

To minimise the systemic side effects of chemotherapy. Assessed through blood samples during the chemotherapy infusion sessions.

Timepoint [3]

During chemotherapy infusion sessions

Secondary outcome [4]

To improve patient's overall quality of life. Determined through questionnaires.

Timepoint [4]

Baseline and 1 month post-explantation

Eligibility

Key inclusion criteria

Colorectal cancer liver metastases patients:
1) Patients must be over 18 years of age
2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
3) Patients must be fit for anaesthesia
4) Patients must have histologically proven colorectal cancer
5) Patients have unresectable hepatic metastases
6) Patient has failed first line therapy
7) Patients' World Health Organization performance status less than or equal to 2
8) Patients have adequate bone marrow
9) Patients have adequate renal function
10) Patients have adequate liver function
11) Patients have normal coagulation

Hepatocellular carcinoma patients:
1) Patient must be over 18 years of age
2) Patients must be able to understand the risks and benefits of the trial and give written informed consent to participate
3) Patients must be fit for anaesthesia
4) Patients have a Child-Pugh score of A or B
5) Patients have failed 1st line therapy
6) Patients have adequate hematology/bone marrow
7) Patients have adequate liver function
8) Patients have normal coagulation

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Colorectal cancer liver metastases patients:
1) World Health Organization performance status > 2
2) Patients have clinically significant ascites
3) Patients have dominant extra-hepatic disease
4) Technical inability to perform HAI
5) Patients have had previous treatment with SIR spheres
6) Patients have Grade 3 or 4 peripheral neuropathy
7) Patients have significant co-morbidities

Hepatocellular carcinoma patients:
1) Child-Pugh score of C
2) Patients have dominant extra-hepatic disease
3) Patients have had previous treatment with SIR-spheres
4) Technical inability to perform HAI
5) Patients have significant co-morbidities
6) Patients have advanced liver failure/complications

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/01/2012

Actual

26/09/2012

Date of last participant enrolment

Anticipated

2/09/2014

Actual

13/01/2015

Date of last data collection

Anticipated

Actual

30/09/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Rodney Lane

Address [1]

Suite 13, Greenwich Square 130-134 Pacific Highway St Leonards NSW 2065

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Rodney Lane

Address

Suite 13, Greenwich Square 130-134 Pacific Highway St Leonards NSW 2065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee (HREC)

Ethics committee address [1]

Research Office
Research Hub, Building C5C East
Macquarie University NSW 2109

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

30/09/2011

Ethics approval number [1]

HREC Reference No: 5201100434

Summary

Brief summary

The study will be recruiting patients with colorectal cancer with liver metastases (CRC-LM) or patients with hepatocellular carcinomas (HCC). The inclusion and exclusion criteria for both CRC-LM and HCC patients can be found in the relevant sections.

This study involves the temporary surgical implantation of a large bore access port (a peripheral access system) in the common femoral artery or the subclavian artery. This procedure will take approximately 2 to 3 hours. You will undergo an operation to have the vascular access device implanted prior to receiving chemotherapy treatment sessions. The chemotherapy treatment sessions will subsequently be given as part of the treatment regime determined by the clinical investigator based on clinical observations. Depending on your response, you will be administered with the liver isolation chemotherapy treatment between 3 to 8 times during the month the device is implanted. After you the final chemotherapy treatment and on the same day, you will then undergo a second operation to remove the device.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rodney Lane

Address

Suite 13, Greenwich Square, 130-134 Pacific Highway, St Leonards NSW 2065

Country

Australia

Phone

+61 2 9438 4500

Fax

+61 2 9438 4114

profrodlane1@gmail.com

Contact person for public queries

Name

Rodney Lane

Address

Suite 13, Greenwich Square,
130-134 Pacific Highway,
St Leonards NSW 2065

Country

Australia

Phone

+61 2 9438 4500

Fax

+61 2 9438 4114

profrodlane1@gmail.com

Contact person for scientific queries

Name

Rodney Lane

Address

Suite 13, Greenwich Square,
130-134 Pacific Highway,
St Leonards NSW 2065

Country

Australia

Phone

+61 2 9438 4500

Fax

+61 2 9438 4114

profrodlane1@gmail.com

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Safety and Feasibility of Repeatable Hepatic Vascular Isolation Chemotherapy: A Pilot Study.	2016	https://dx.doi.org/10.1245/s10434-016-5198-z

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically