Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000354583
Ethics application status
Approved
Date submitted
1/08/2006
Date registered
16/08/2006
Date last updated
16/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Neoadjuvant Chemotherapy for Colorectal Liver Metastases on Functional Hepatic Reserves as Assessed by Indocyanine Green Clearance - A Pilot Study.
Scientific title
Effects of neoadjuvant chemotherapy for colorectal liver metastases on functional hepatic reserves as assessed by Indocyanine Green Clearance.
Secondary ID [1] 294 0
Clinical Trial Notification (CTN): 2006/314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Liver Metastases 1324 0
Condition category
Condition code
Cancer 1411 1411 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 1412 1412 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
·Stage one involves patients that have colorectal liver metastases and who need to undergo chemotherapy to help reduce the size of liver metastases. These patients may or may not proceed to a liver resection. The treating doctor will monitor each patient’s progress and determine if the patient is medically stable to undergo such an invasive procedure, once chemotherapy treatment has ceased. The patients who proceed to liver resection are given the opportunity to take part in stage two of this study. Chemotherapy would most likely be 5-Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX). Dose and mode are dependant on the patients treatment as deemed appropriate by the oncologist. Duration: Approximately 9 months

·Stage two involves comparing patients who have had chemotherapy treatment with patients who have not had chemotherapy for their colorectal liver metastases. This stage is designed to see how quickly the liver regenerates after chemotherapy and surgery compared to patients who have not undergone chemotherapy. Patients from stage one who are able to have liver resection surgery will be given the opportunity to join stage two of the study. The groups of patients for Stage 2 resection are discussed at a weekly Upper GI meeting at the QEH and at this time they are either deemed eligible or not. Duration: Approximately 6 months
Intervention code [1] 1236 0
Treatment: Other
Comparator / control treatment
Patients who have not had chemotherapy for their colorectal liver metastases.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1933 0
To determine the optimal time for liver regeneration and liver resection in patients who have undergone neoadjuvant chemotherapy for colorectal liver metastases, as assessed by Indocyanine Green Clearance dye.
Timepoint [1] 1933 0
The outcome will be assessed after 10 patients to ascertain if the trial is producing any results (given that it is a pilot study).
Secondary outcome [1] 3393 0
To investigate the potential correlation of changes over time from neoadjuvant chemotherapy in parenchyma function using Indocyanine Green Clearance dye.
Timepoint [1] 3393 0
The outcome will be assessed after 10 patients to ascertain if the trial is producing any results (given that it is a pilot study).

Eligibility
Key inclusion criteria
Written, informed consent to participate in trial.·Patients undergoing neoadjuvant chemotherapy for resectable/unresectable colorectal metastases or, ·Patients undergoing liver resection for resectable colorectal metastases. ·Patients who have either never had chemotherapy or who have undergone chemotherapy previously (excluding 12 months prior to enrolment in this trial).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are pregnant or who are breast-feeding. It is unknown if ICG can cause harm to a foetus or baby.·A history of allergy to iodides as ICG contains sodium iodide and should be used with caution. ·Patients whom the investigator does not see fit to be involved in this study. ·Patients who have undergone chemotherapy in the last 12 months.·Patients who are unable to give informed consent.Precautions·Radioactive iodine uptake studies should not be performed for at least a week following the use of ICG.

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
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1544 0
Hospital
Name [1] 1544 0
The Department of Surgery Departmental Funding
Country [1] 1544 0
Primary sponsor type
Individual
Name
Professor Guy J Maddern
Address
Country
Secondary sponsor category [1] 1357 0
None
Name [1] 1357 0
Nil
Address [1] 1357 0
Country [1] 1357 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2974 0
Central Northern Adelaide Health Service Ethics of Human Research Committee
Ethics committee address [1] 2974 0
Ethics committee country [1] 2974 0
Australia
Date submitted for ethics approval [1] 2974 0
Approval date [1] 2974 0
Ethics approval number [1] 2974 0
2005129

Summary
Brief summary
The purpose of this stage of the study is to find out how well the livers of patients who have undergone chemotherapy and/or a liver resection regenerate after surgery compared to the livers of patients who have not undergone chemotherapy treatment.

We are conducting this study because post-surgery assessment of liver function and the prediction of how well the liver functions after surgery in patients who have undergone chemotherapy and/or liver resection has not been examined. We will find this information out by conducting a liver function test using Indocyanine Green Clearance dye (ICG). This test provides us with an indication of how well your liver is functioning at a point in time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35523 0
Address 35523 0
Country 35523 0
Phone 35523 0
Fax 35523 0
Email 35523 0
Contact person for public queries
Name 10425 0
Catherine Easterbrook
Address 10425 0
Department of Surgery
The Queen Elizabeth Hospital
28 Woodville Road Woodville South SA 5011
Country 10425 0
Australia
Phone 10425 0
+61 8 82226852
Fax 10425 0
+61 8 82226028
Email 10425 0
catherine.easterbrook@adelaide.edu.au
Contact person for scientific queries
Name 1353 0
Professor Guy Maddern
Address 1353 0
Department of Surgery
The Queen Elizabeth Hospital
28 Woodville Road Woodville South SA 5011
Country 1353 0
Australia
Phone 1353 0
+61 8 82226750
Fax 1353 0
+61 8 82226028
Email 1353 0
guy.maddern@adelaide.edu.au

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
No additional documents have been identified.