Colorectal

The following list provides a brief description of colorectal cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.

Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.

Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.

 

Advanced metastatic colorectal cancer

Registered Title

An open-label early access phase IIIb study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.

Purpose

An early access study of trifluridine / tipiracil (S 95005/TAS-102) in patients with a pretreated metastatic colorectal cancer.

Lay Summary

The research project is testing trifluridine/tipiracil (also known as S95005 or TAS-102) in patients with metastatic colorectal cancer. It is offered as a third line ( or later ) treatment.The drug is given orally (10 days of treatment every 28 days) and is approved in Japan , United States and in the European Union under the trade name of Lonsurf®.It has not been approved treatment for metastatic colorectal cancer in Australia and is therefore an experimental treatment.

WA Trial Sites

Mount Hospital logo

Mount Hospital Clinical Trials
(08) 9481 8373

Link

EU Clinical Trials Register

Acknowledgements: EU Clinical Trials Register

 

ALT GIST Study

Registered Title

A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST).

Purpose

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

Lay Summary

An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

ASCOLT Study

Registered Title

Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial.

Purpose

We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally..

Lay Summary

N/A

WA Trial Sites

Sir Charles Gairdner Hospital Logo

SCGH Medical Oncology
Ph. (08) 6383 3000

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

CHALLENGE Study

Registered Title

A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High Risk Stage II or Stage III Colon Cancer: A Randomized Controlled Trial (CHALLENGE)

Purpose

This randomized phase III trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

Lay Summary

Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment.

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

DYNAMIC Study

Registered Title

A study to evaluate the use of circulating tumour DNA to guide adjuvant chemotherapy on recurrence-free survival in patients with stage II Colon or rectal cancer.

Purpose

This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients.

Lay Summary

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with Stage II colon or rectal cancer and have had your cancer curatively resected.

Study details:

Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy (either single agent or combined with oxaliplatin), while those with negative ctDNA will not receive adjuvant chemotherapy. Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician. Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. All participants will be followed up 3 monthly for 2 years, then 6 monthly for 3 years through their hospital for a total of five years for disease recurrence and survival.

WA Trial Sites

Fiona Stanley Hospital Logo

Cancer Centre Clinical Trials Unit
Caroline Stone
Clinical Trials Manager
Phone 08 615 26530 Fax 08 615 20954
caroline.stone@health.wa.gov.au

Links

Australian New Zealand Clinical Trials Registry

Acknowledgements: Australian New Zealand Clinical Trials Registry

 

KEYNOTE-177

Registered Title

A Phase III Study of Pembrolizumab (MK-3475) vs. Chemotherapy in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (KEYNOTE-177).

Purpose

In this study, participants with MSI-H or dMMR advanced colorectal carcinoma will be randomly assigned to receive either pembrolizumab or the Investigator's choice of 1 of 6 standard of care (SOC) chemotherapy regimens for the treatment of advanced colorectal carcinoma. The primary study hypothesis is that pembrolizumab will prolong progression-free survival (PFS) compared to current SOC chemotherapy.

Lay Summary

N/A

WA Trial Sites

St John of God Healthcare logo

St John of God
Ph. (08) 6465 9204

Links

US National Library of Medicine

Acknowledgements: US National Library of Medicine

 

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