FORECAST-II Feasibility of using Organoid Response to inform treatments for patients with Colorectal cancer staring first-line therapy
- Conditions
- Colorectal CancerCancer - Bowel - Back passage (rectum) or large bowel (colon)
- Registration Number
- ACTRN12624000684527
- Lead Sponsor
- Walter and Eliza Hall Institute of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 140
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To explore the feasibility of chemosensitivity testing of tumour organoids to guide clinical decision making for locally advanced and unresectable or metastatic CRC patients in the first- and second-line treatment setting.[Feasibility will be measured by how many patients successfully have an organoid established from their tumour tissue and drug tested, Aim is 70% of participants. This will be at first restaging, Between 12-16 weeks from time enrolment..]
- Secondary Outcome Measures
Name Time Method Optimal selection of metastatic sites or primary tumour tissue.[fluorodeoxyglucose positron emission tomography (FDG-PET) Approximately 12 weeks post biopsy, before commencement of Cycle 1 of first line treatment.]