RecruitingACTRN12606000354583

The Effects of Neoadjuvant Chemotherapy for Colorectal Liver Metastases on Functional Hepatic Reserves as Assessed by Indocyanine Green Clearance - A Pilot Study.

Effects of neoadjuvant chemotherapy for colorectal liver metastases on functional hepatic reserves as assessed by Indocyanine Green Clearance.


Sponsor

Professor Guy J Maddern

Enrollment

40 participants

Start Date

Feb 1, 2006

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at how well the liver recovers after surgery in people who have had chemotherapy for bowel cancer that has spread to the liver. When cancer from the bowel spreads to the liver, surgeons can sometimes remove (resect) those areas. However, chemotherapy can affect liver function, making recovery from surgery more difficult. Researchers will use a safe dye called Indocyanine Green (ICG) to measure how well the liver is working before and after surgery, to better understand the effects of chemotherapy on liver recovery. You may be eligible if: - You are 18 years of age or older - You are about to receive chemotherapy for bowel cancer that has spread to the liver, OR - You are about to have surgery to remove bowel cancer that has spread to the liver - You have either never had chemotherapy, OR you had chemotherapy more than 12 months ago - You are willing to give informed consent You may NOT be eligible if: - You are pregnant or breastfeeding - You have a known allergy to iodine (the ICG dye contains sodium iodide) - You have received chemotherapy in the last 12 months - You are unable to give informed consent Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

·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 re

·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


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12606000354583


Related Trials