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Trial Status

In Development

Cancer Type

Colorectal Cancer

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

Background

There is a large unmet need for patients with metastatic colorectal cancer (mCRC) that have failed standard therapy and remain fit for further treatment. Currently, clinical trials are often considered in this setting, however these are not always readily accessible or suitable trials may not be available. Subsequently, treating clinicians may retreat (rechallenge) with a previously used chemotherapy, or suggest that patients self-fund proven agents that are not currently available on the PBS.

There have been many recent successes in growing cancer cells derived from biopsies of individual patient tumours in the laboratory – called patient derived tumor organoids (PDTOs). PDTOs provide a promising model for personalized therapy, as we can pre-test anti-cancer treatments on patients’ individual cancers, to determine the most likely effective treatment for that patient. The Walter and Eliza Hall Institute of Medical Research have successfully cultured these mini-cancers from > 100 patients with colorectal cancer. By growing these mini-cancers in 384-well plates, we can test a large variety of drugs, different drug concentrations, and different drug combinations for treatment effect.

When a patient is sick from a bacterial infection, standard practice is to culture the organism causing the illness in the laboratory to test for sensitivities and resistance of antibiotics which will best guide the correct treatment in clinical practice. However, cancer treatment continues to be largely based upon tumour histology (or organ of origin), limiting the ability to predict benefit in each individual patient. “Bucket clinical trials” are a new development in precision oncology, where individual cancers are genetically interrogated, with treatment individually allocated according to the results of these analyses. Similarly, pre-treatment drug sensitivity testing could be used to inform treatment selection. Sensitivity testing of PDTOs is a promising new method to enable treatment selection in the cancer setting.

Trial Status

In Development

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

Feasibility of Organoid Response assessment to define Effective Treatments for patients with Colorectal cancer After failure of Standard Therapy.

AIM

Primary Objective

  • To demonstrate the feasibility of a prospective PDTO informed approach to mCRC treatment selection

Secondary Objectives

  • To determine the proportion of patients where a PDTO culture can be established and sensitivity data provided to clinicians within 4-6 weeks
  • To determine the proportion of patients where PDTO sensitivity testing informs treatment selection
  • To explore the correlation between PDTO drug sensitivity and clinical benefit, including for lonsurf

Key Eligibility Criteria

Inclusion Criteria

  1. Patients with a life expectancy of > 3 months
  2. Performance status 0-1
  3. Patients that have failed or are intolerant of standard therapies (excluding lonsurf)
  4. Patients with adequate major organ function

Exclusion Criteria

  1. Patients where a biopsy to obtain fresh tissue cannot be safely performed

Principal Investigator

Prof Peter Gibbs