FORECAST-1
  • FORECAST-1
    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.

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.

The Walter and Eliza Hall Institute of Medical Research have successfully cultured these mini-cancers from over 100 patients with colorectal cancer. By growing these mini-cancers, we can test a large variety of drugs, different drug concentrations, and different drug combinations for treatment effect.

KEY ELIGIBILITY CRITERIA

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

Principal Investigator

Professor Peter Gibbs

DETAILED INFORMATION AVAILABLE

More detailed information to come.

Funding

2019 Innovation Fund Grant

Participating Centres

Victoria
Melbourne Private Hospital
Box Hill Hospital/Eastern Health
Sunshine Hospital/Western Health

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

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

Participating Centres

Victoria
Melbourne Private Hospital
Box Hill Hospital/Eastern Health
Sunshine Hospital/Western Health

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