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RecruitingLast updated: 29 April 2026

FORECAST-II: This study is recruiting people with advanced bowel cancer in both first- and later-line treatment settings to assess whether a lab test using patient tumour samples can help predict which treatments are most likely to workFeasibility of using Organoid Response to inform treatments for patients with Colorectal cancer staring first-line therapy

Trial purpose

Medical clipboardCancer treatment; Diagnostic

Tumor type

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Trial acronym

FORECAST-II

Clinical summary

Summary

This study is to evaluate the potential of a lab test using patient tumour samples (called tumour organoid response) to predict the clinical benefit that individual patients may get from available anti-cancer treatments for advanced bowel cancer, in both the first- and later-line therapy settings.

Who is it for?
You may be eligible for this study if you are an adult with a diagnosis of colorectal cancer that is either locally advanced and unable to be removed with surgery (unresectable), or metastatic. You should not have received treatment (e.g. chemotherapy) for this stage of disease and be otherwise fit enough to undertake treatment.

Study details
The study will involve obtaining biopsies, initially and at the time of cancer progression, and using standard and new blood tests. 

Patients will receive standard of care treatment at the discretion of their Oncologist (this is standard practise, done for those not participating in clinical trials also). 

The consistency of results between expanded panel (TSO500) based testing of tumour tissue and laboratory-based profiling of the matrched PDTO will be examined.

It is hoped that these results will help improve decision making by clinicians and ultimately individualise patients' treatment to improve outcomes. It is hoped the findings from this study will establish reliable preclinical models that will enable high throughout drug testing to guide optimal treatment selection in daily clinical practice in the future, and potentially inform treatment selection of standard of care agents in first and later line treatment. 

 

Conditions

This trial is treating people with advanced bowel cancer who have not yet received systemic treatment but are planning to

Eligibility

Inclusion

1 Be able to provide informed, voluntary, written consent.
2 Have a diagnosis of CRC that is either locally advanced and unresectable, or metastatic.
3 Have ECOG performance status of 0-2.
4 Have adequate major organ function.
5 Be fit to receive systemic treatment.
6 Be planning to receive systemic treatment.
7 Have chemotherapy-naïve disease in the advanced setting. Prior chemotherapy in the
neo/adjuvant setting is permitted for those with relapsed disease.
8 Have a life expectancy of > 3 months.
9 Be accessible for follow up and data collection.
10 Be willing and able to undergo initial tumour biopsy and provide serial blood samples.
11 Be willing to provide archival tumour tissue or fresh tumour tissue for genetic testing

Exclusion

1 Cannot undergo biopsy of tumour tissue either due to patient factors (such as being unable to withhold anticoagulation) or tumour factors (location, size inappropriate to biopsy).

2 Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

3 Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study.

Inclusion

  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:

Trial sponsor

Walter and Eliza Hall Institute of Medical Research

Scientific Title

Feasibility of using Organoid Response to inform treatments for patients with Colorectal cancer staring first-line therapy

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