Trial Status


Cancer Type

Colorectal Cancer

Protocol Title

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

Purpose of the Study

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.

FORECAST-1 aims to demonstrate the feasibility of utilising tumour organoids established from fresh tumour biopsies of mCRC for high throughput drug testing to guide clinical decision making.


Inclusion Criteria

  • Able to provide informed, voluntary, written consent
  • Have a diagnosis of metastatic colorectal cancer
  • Are able to safely undergo biopsy to provide samples of fresh tumour
  • ECOG performance status of 0-2
  • Have adequate major organ function
  • Fit for further systemic treatment
  • Have failed or are intolerant of standard therapies (excluding trifluridine/tipiracil)
  • Prior systemic treatment must have discontinued at least 2 weeks prior to enrolment onto the study
  • Have a life expectancy of > 3 months
  • Are accessible for follow up and de-identified coded data collection

Exclusion Criteria

  • Have a condition that interferes with their ability to provide informed consent or comply with the protocol
  • Unable to provide tissue samples for any reason

Study Chair

Professor Peter Gibbs


Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here.


2019 Innovation Grant

Trial Status


Cancer Type

Colorectal Cancer

Protocol Title

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


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

Principal Investigator

Prof Peter Gibbs