Concept Outline Form

This is the Concept Outline Form for the New Concepts Symposium, held at the Annual Scientific Meeting.

Please complete all relevant sections of the form. If you have any questions, or require assistance completing this form, please contact research@gicancer.org.au and bridget@gicancer.org.au. Late applications will not be considered.

You can choose Save and Complete Later at every page.

The form consists of 10 pages:

A. Title and administrative information
B. Science
C. Study design
D. Embedded correlative study
E. Feasibility
F. Equity, diversity and inclusion
G. Study drug
H. Discussion points and references
I. Presentation and publication
J. Submission.

Note on submission eligibility

To submit your concept, the person submitting this form, the nominated Study Chair and Co-Chair(s), and the presenter of the concept if selected must be a GI Cancer Trials member and hold a valid COID with GI Cancer Trials. You will be asked about this at the end of the form.

Finalise your concept outline

Congratulations on progressing to the New Concept Symposium!

The following is the application you originally submitted. Please update any relevant details that have since changed.

If you have any questions, or require assistance completing this form, please contact research@gicancer.org.au and bridget@gicancer.org.au.

You can choose Save and Complete Later at every page, but you can only click the 'Submit' button once. After you have clicked the 'Submit' button, your updates will be considered final.

The form consists of 10 pages:

A. Title and administrative information
B. Science
C. Study design
D. Embedded correlative study
E. Feasibility
F. Equity, diversity and inclusion
G. Study drug
H. Discussion points and references
I. Presentation and publication
J. Submission.

You are currently updating your concept outline. The submitter email address cannot be changed.

Submitter email address *

Page 1 of 10

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A. Title and administrative information

Trial information

Full title of trial *

Title acronym *Acronym only. Max: 15 characters

Disease type *

Please specify the disease type. *

Phase *

Phase IIPhase IIIN/A (Please elaborate under "Type of trial")

Where applicable.

Type of trial *E.g., pilot, interventional, translational or biomarker

GI Cancer Trials Study Chair

Title *

First name *

Last name *

No last name applicable

Email address *

GI Cancer Trials Study Co-Chair(s)

Consider inviting an early career researcher to support succession planning.

Title *

Full name *

Email address *

To delete any additional rows, hover over the row you'd like to delete, and then click the X to the right of the row.

Funding plans

Please indicate the following:*

Are there funding applications that are planned, pending outcomes, or have been unsuccessful?
Do you plan to apply for funding for this trial from GI Cancer Trials?

Page 2 of 10

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B. Science

Note on supplementary figures, tables and charts:

Section B will ask for details on your concept. If you refer to any supplementary figures, tables and/or charts in Section B, please compile them and upload in a single document. This will help streamline the time our team requires in reviewing your concept submission.

Supplementary figures, tables and charts

Browse

Lay summary

In 250–300 words, please describe the trial in lay terms, specifically how the outcomes from this study will benefit the community, including the following topics:*

Overall aim
Background and importance of unmet need
Brief overview of primary and secondary outcomes
Brief overview of study design/methods
Expected impact on quality of life, symptoms, or other patient burdens (e.g., time)
Anticipated impact (short- and long-term) that this study will have to patients/community
Inclusion of patients, carers, or community in proposal development.

If required, please contact Clinical Trial Development Team to be linked in with the Community Advisory Panel for concept development purposes at research@gicancer.org.au.

Max: 350 words (1600 characters)

Expanded answers

Describe how the proposed concept addresses an area of unmet clinical need. *

Describe how and whether this study aims to extend life, improve quality of life, or both. *

Outline the aim(s) and objective(s). *

Outline the rationale for the study design and outcomes/endpoints. *

Discuss whether the concept includes any of the following value-added components, and the potential impacts as applicable: *

Quality of life
- If yes, please specify the patient-reported outcomes you are seeking to explore (e.g., aspects, symptoms, or side effects), the Patient Reported Outcome Measures that you are planning to use, and the timepoints where data will be collected.
Health economics
Supportive care
Bioinformatics.

Systematic review

What previous research has occurred? *

Is a published systematic review available? *

NoYes

Discuss relevant data that justify the use of the control and experimental arms. *Include Phase I-III trial results, and any pilot or confidential data from companies.

If successful, describe how the research can be translated to improve patient care. *

If successful, describe how the research will generate data or expertise to support further large-scale research. *

Discuss how this trial fits with the GI Cancer Trials Research Strategy.*

Our Research Strategy can be found at gicancer.org.au/research.

Page 3 of 10

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C. Study design

Target population

Include rationale for including or excluding particular cohorts.

Inclusion criteria *

Exclusion criteria *

Trial design

You have indicated that this will be a Phase I trial.

You have indicated that this will be a Phase II trial.

You have indicated that this will be a Phase III trial.

You have indicated that phases are not applicable to this study.

Randomisation *

Study schema *

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Please upload a study schema.

Describe the treatment arms/regimens. *

Describe the proposed study visit frequency, including frequency of study treatment delivery, safety visits, and/or frequency of collection (QoL, TR samples such as blood and tissue). *

Statistical design

Primary endpoint *

Secondary endpoint(s) *

Include any stratification to be used in the randomisation. *

Provide sample size with power justification. *

Provide analysis plan including plans for formal interim analysis. *

Page 4 of 10

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D. Embedded correlative study

At this stage, does this concept involve translational research? *

No, it will not involve translational researchNo, not yet at this stageYesN/A

Please list the aims and objectives of this translational research. *

Please describe the substudy, including: analytical methods, samples analysed, resources required to complete the study, and substudy outcomes. *

Please detail the expertise and experience of the Investigator team that is required to successfully complete the substudy outcomes. *

Page 5 of 10

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E. Feasibility

Please list competing trials in Australia. *

Please list competing trials conducted by other groups or company studies of which you are aware. *

If the trial is a proposed intergroup or international trial to be led by GI Cancer Trials, please list other groups/countries that have stated interest or commitment to the trial. *

Please review current clinical trials listed on the WHO International Clinical Trials Registry Platform to find similar studies. *

You can search the Registry at trialsearch.who.int.

No, there are no similar current studiesYes, there are similar current studies

Similar current studies listed *

Page 6 of 10

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F. Equity, diversity and inclusion

Before responding this section, we invite you to review the following resources:

Specify how First Nations, Torres Strait Islander, and/or Māori participants and stakeholders were or will be involved in the research process. *

Discuss whether the concept will advance equitable cancer care by increasing clinical trial participation from:*

Rural, regional and remote populations
Patients from culturally and linguistically diverse backgrounds
Aboriginal, Torres Strait Islander, and Māori peoples.

Discuss whether the concept includes a teletrial model. *

Please provide a rationale if no teletrial model is anticipated.

Describe how the proposed concept promotes equity of care via the following:*

Access to trials throughout Australia and New Zealand (including metropolitan, regional, rural and remote areas)
Equitable trial design
Availability and affordability of treatment
Sustained access to chemotherapy, radiotherapy, and/or medical imaging (as applicable to the study)
Sustainability of research benefits following the study completion.

Page 7 of 10

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G. Study drug

Does the study require provision of drug(s) or device(s) to participants as an intervention? *

NoYes

Is the study drug(s) or device(s) being investigated available for use in the indication in Australia and Aotearoa New Zealand as standard-of-care? *

NoYes

Does the study require submission to the Therapeutic Goods Administration (via CTN) or MEDSAFE? *

NoYes

Please discuss whether there are any study drug storage, expiry, compounding, dispensation or administration elements that would prevent or limit teletrial participation from a study drug perspective. *

Page 8 of 10

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H. Discussion points and references

Please add any discussion points relevant to this concept. *

Please add below your list of references from this submission. *

Page 9 of 10

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I. Presentation and publication

Presenter information

For promotional purposes, please provide the following for the nominated presenter, should this concept be selected.

If you are unsure about who may present, please provide the following for the nominated Study Chair.

Please upload a photo of the presenter. *

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Please provide a short bio of the presenter. *

Publication and promotion

Please note that if this concept is chosen for presentation at the New Concepts Symposium, the following details will be published across promotional materials and content for the Annual Scientific Meeting:

the full title of the concept
the title and full name of the presenter and nominated Study Chairs and Co-Chairs.

We endeavour to tag relevant individuals to chosen concepts in our social media channels.

Does the presenter or Study Chair have a LinkedIn account? *

YesNo

URL of relevant LinkedIn user page(s) *If this concept is selected for the New Concepts Symposium, we will tag these pages.

Page 10 of 10

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J. Submission

Confirmation of membership

The following persons must be members of GI Cancer Trials:

the person submitting this concept
concept presenter, if this concept is chosen
nominated Study Chairs and Study Co-Chairs.

If you are not yet a member, applying for membership is free and takes approximately 5 minutes.

Does everyone falling under the above categories currently hold GI Cancer Trials membership? *

YesNo

The following people must be current GI Cancer Trials members:

a. the person submitting this form
b. presenter of the concept, if this concept is selected
c. nominated Study Chair or Co-Chair(s).

Join GI Cancer Trials here
Avg. completion time: 5 mins

You will not be able to submit your concept at present. Please click Save and Complete Later below, then return once you have lodged a membership application. Thank you.

Confirmation of COID submission

The following persons must have submitted a valid Conflict of Interest Declaration (COID) in the past 12 months:

the person submitting this concept
concept presenter, if this concept is chosen
nominated Study Chairs and Study Co-Chairs.

This includes if there are no conflicts or benefits to declare. Submitting your COID takes approximately 3 minutes.

Does everyone falling under the above categories have a valid COID with GI Cancer Trials in the past 12 months? *

YesNo

The following people must hold a valid COID with GI Cancer Trials:

a. the person submitting this form
b. presenter of the concept, if this concept is selected
c. nominated Study Chair or Co-Chair(s).

The COID must have been submitted in the past 12 months. This includes if there are no conflicts or benefits to declare.

Submit a COID here
Avg. completion time: 3 mins

You will not be able to submit your concept at present. Please click Save and Complete Later below, then return once you have lodged a membership application. Thank you.

Confirmation of in-person attendance

I have noted and confirm that the presenter of this concept will be required to register for the Annual Scientific Meeting and attend the New Concepts Symposium in person. *

Agreement to not record, transcribe or capture

Presenters at the New Concept Symposium are generously sharing their original research and clinical work with attendees. I acknowledge that attendee usage of any technology, including AI technology such as bots and AI personal assistants, to privately record, transcribe, or capture images from the presentation of selected concepts is strictly prohibited. Any breach of this policy will result in immediate removal from the session. Presenters may contact our team for professionally taken event photography after the session.

I agree not to employ any technology, including AI technology such as bots and AI personal assistants, to record, transcribe, or capture images from the New Concepts Symposium. *

Privacy Policy

I consent to my data being collected and stored for the purposes of concept submission, per the Privacy Policy terms at gicancer.org.au/privacy. *

Person completing concept submission

Title *

Full name *

Signature *

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