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Trial registered on ANZCTR


Registration number
ACTRN12624000684527p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2024
Date registered
29/05/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
29/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
FORECAST-II Feasibility of using Organoid Response to inform treatments for patients with Colorectal cancer staring first-line therapy
Scientific title
FORECAST-II Feasibility of using Organoid Response to inform treatments for patients with Colorectal cancer staring first-line therapy
Secondary ID [1] 311995 0
NIL KNOWN
Universal Trial Number (UTN)
Trial acronym
FORECAST-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 333363 0
Condition category
Condition code
Cancer 330049 330049 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will collect fresh tumour biopsies from sites of metastases (liver metastases if possible) or the colorectal primary, in patients with treatment-naive, locally advanced and unresectable mCRC, at baseline and disease progression- (can't predict timeframe for progression-determined by radiological growth or clinical symptoms). This will be done via a core-needle or excisional biopsy, or open surgical procedure ,by surgeon or radiologist. It is for the purpose of generating a patient derived tumour organoid (PDTO) culture. PDTO will be used to test 10-12 drugs. At the same time as biopsy, 30 - 60mL of whole blood will also be collected for the purposes of germline genomic evaluation, ctDNA analysis and collection of PBMC for co-culture with PDTO. This will be collected by pathology department or a delegated nurse.. The aim is to establish reliable preclinical models that will enable high throughput 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 second-line treatment and beyond.
Intervention code [1] 328288 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337812 0
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.
Timepoint [1] 337812 0
This will be at first restaging, Between 12-16 weeks from time enrolment..
Secondary outcome [1] 433376 0
Optimal selection of metastatic sites or primary tumour tissue.
Timepoint [1] 433376 0
Approximately 12 weeks post biopsy, before commencement of Cycle 1 of first line treatment.

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to analize data arising directly from this study. The Kaplan-Meier method and Mantel-Cox log-rank test will be used for survival analyses. Proportions will be compared using the Chi square method or Fisher’s exact test. For all analyses, two-sided p values of <0.05 will be considered significant. Multivariate survival analyses will use the Cox Proportional Hazards Method.
Using the method of Mehta-Cain, a total sample size of 140 patients with mCRC receiving standard of care treatment will be recruited to confirm at least a 70% uptake (=98 patients receive a standard chemotherapy +/- biologic, for which there is matching PDTO sensitivity data), which would inform the design of a future study of PDTO informed treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26330 0
Eastern Health - Box Hill
Recruitment hospital [2] 26331 0
Western Hospital - Footscray - Footscray
Recruitment hospital [3] 26332 0
Latrobe Regional Hospital - Traralgon
Recruitment hospital [4] 26333 0
The Northern Hospital - Epping
Recruitment hospital [5] 26334 0
Melbourne Private Hospital - Parkville
Recruitment hospital [6] 26335 0
Western Private Hospital - Footscray
Recruitment postcode(s) [1] 42304 0
3128 - Box Hill
Recruitment postcode(s) [2] 42305 0
3011 - Footscray
Recruitment postcode(s) [3] 42306 0
3844 - Traralgon
Recruitment postcode(s) [4] 42307 0
3076 - Epping
Recruitment postcode(s) [5] 42308 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 316177 0
Government body
Name [1] 316177 0
Cancer Australia’s Priority-driven Collaborative Cancer Research Scheme 2022
Country [1] 316177 0
Australia
Funding source category [2] 316179 0
Commercial sector/Industry
Name [2] 316179 0
Haystack Oncology, Inc
Country [2] 316179 0
United States of America
Primary sponsor type
Other
Name
Walter and Eliza Hall Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 318362 0
None
Name [1] 318362 0
Address [1] 318362 0
Country [1] 318362 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314999 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 314999 0
https://www.thermh.org.au/research/researchers/ethics
Ethics committee country [1] 314999 0
Australia
Date submitted for ethics approval [1] 314999 0
25/10/2023
Approval date [1] 314999 0
Ethics approval number [1] 314999 0

Summary
Brief summary
This study is to evaluate the potential of tumour organoid response to predict the clinical benefit that individual patients will derive from available anti-cancer therapies for advanced CRC, in the first- and later-line therapy settings.
Who is it for:
You may be eligible for this study if you are an adult male or female with a diagnosis of CRC that is either locally advanced and unresectable, or metastatic, have not received treatment (ie chemotherapy) for this stage of disease and otherwise are fit enough to undertake treatment.
Study details:
The study will involve obtaining biopsies initially and at time of progression and using standard and novel blood tests. The consistency of results between expanded panel (TSO500) based testing of tumour tissue and laboratory-based profiling of the matched PDTO will be examined.

It is hoped that these results will help improve decision making by clinicians and ultimately individualise patient's treatment to improve outcomes.

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). It is hoped that findings from this study will establish reliable preclinical models that will enable high throughput 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133374 0
Prof Peter Gibbs
Address 133374 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 133374 0
Australia
Phone 133374 0
+61 03 9345 2555
Fax 133374 0
Email 133374 0
[email protected]
Contact person for public queries
Name 133375 0
Kelsy Serena
Address 133375 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 133375 0
Australia
Phone 133375 0
+61 039345 2146
Fax 133375 0
Email 133375 0
[email protected]
Contact person for scientific queries
Name 133376 0
Dr Shehara Mendis
Address 133376 0
Walter and Eliza Hall Institute of Medical Research 1G Royal Parade, Parkville, Victoria 3052
Country 133376 0
Australia
Phone 133376 0
+61 03 9345 2122
Fax 133376 0
Email 133376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data after de-identification.
When will data be available (start and end dates)?
Once data is available, reviewed and may be useful in determining further lines of treatment. No date/timeframe determined.
Available to whom?
To researchers on a case-by-case basis at the discretion of Primary Sponsor, considered on merits of request.
Available for what types of analyses?
to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
subject to approvals by Principal Investigator
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.