LIBERATE

Share

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

AIM

The purpose of this study is to investigate “liquid biopsies” as a method of evaluating RAS mutation status in patients with advanced colorectal cancer. This involves determining the accuracy of results of “liquid biopsies”, compared to genetic testing of cancer tissue. Different methods of testing “liquid biopsies” will be studied and compared. The study will also assess whether the ability of “liquid biopsies” to detect cancer gene mutations is different at different time points.

SUMMARY

This study is a prospective cohort study that will recruit 100 patients at approximately 10-15 sites in Australia. The study will recruit patients with advanced colorectal cancer who have not received previous chemotherapy. The results of “liquid biopsies” will not direct an individual patient’s treatment in this trial.

Participating Centres

New South Wales
Nepean Cancer Centre
Border Medical Oncology
Queensland
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Tasmania
Royal Hobart Hospital
Victoria
St Vincents Hospital, Melbourne
Austin Health
Monash Medical Centre
Western Australia
Fiona Stanley Hospital

Trial Status

Open

Cancer Type

Colorectal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Protocol Title

A study evaluating liquid biopsies to profile metastatic colorectal cancer

AIM

Primary Objective:
To validate liquid biopsies as an alternative to tissue based
assays to determine ras status

Secondary Objectives:
–  To compare different modalities of evaluating mutation
status in ctDNA
– To assess the impact of timing of sample collection on
detection of mutation status
TRIAL DESIGN

BACKGROUND

Colorectal cancer is the most commonly diagnosed cancer in the Australian population. Surgery, with or without chemotherapy and radiotherapy, can be used to cure colorectal cancer that is diagnosed early. Most cases of advanced colorectal that have spread to other organs cannot be cured. Advanced colorectal cancer is treated with chemotherapy and other drugs, known as targeted therapies.

One type of targeted therapy used to treat advanced colorectal cancer is antibodies targeted against the epithelial growth factor receptor (EGFR). Examples of EGFR-targeted antibodies include cetuximab and panitumumab. EGFR-targeted antibodies are only effective in patients with colorectal cancers that do not have mutations in certain genes, known as KRAS and NRAS. Cetuximab and panitumumab do not work in colorectal cancers with mutations in the KRAS or NRAS genes. Therefore, for each patient with advanced colorectal cancer, it is important to assess whether there are mutations in KRAS and NRAS genes in order to determine if EGFR-targeted antibodies will be effective. This process is known as evaluation of RAS mutation status.

CLINICAL TRIAL DESIGN

This study is a prospective cohort study that will recruit 100 patients at approximately 10-15 sites in Australia. The study will recruit patients with advanced colorectal cancer who have not received previous chemotherapy. The results of “liquid biopsies” will not direct an individual patient’s treatment in this trial. All cancer treatments will be chosen by the doctor treating each patient.

Patients Recruited

Click to access the table and view recruitment data on all open AGITG trials:

Open Trial Recruitment Table

Participating Centres

New South Wales
Nepean Cancer Centre
Border Medical Oncology
Queensland
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Tasmania
Royal Hobart Hospital
Victoria
St Vincents Hospital, Melbourne
Austin Health
Monash Medical Centre
Western Australia
Fiona Stanley Hospital

Key Eligibility Criteria

Inclusion criteria
i) Histological diagnosis of metastatic colorectal cancer
ii) Resectable or un-resectable metastatic disease
iii) Age > 18 years
iv) ECOG performance status 0-2
v) No prior chemotherapy except for adjuvant chemotherapy.
vi) No other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of
the uterine cervix or any other cancer treated with curative intent >2 years previously
without evidence of relapse
vii) Written informed consent

Exclusion criteria
i) Medical or psychiatric conditions that compromise the patient’s ability to give informed
consent or to complete the protocol
ii) Pregnancy or lactation

Contact Email

liberate@ctc.usyd.edu.au

Principal Investigator

A/Prof Niall Tebbutt