Clinical Trial Details

Use of circulating tumour DNA (ctDNA) results to inform the decision for adjuvant chemotherapy in patients with locally advanced rectal cancer who have been treated with pre-operative chemo-radiation and surgery.

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
ACT,NSW,NT,WA,VIC

Hospital
Western Hospital - Footscray - Footscray
Western Private Hospital - Footscray
Royal Melbourne Hospital - City campus - Parkville
Melbourne Private Hospital - Parkville
Box Hill Hospital - Box Hill
The Northern Hospital - Epping
Peter MacCallum Cancer Centre - Melbourne
Cabrini Hospital - Malvern - Malvern
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Lake Macquarie Private Hospital - Gateshead
Calvary Mater Newcastle - Waratah
The Alfred - Melbourne
The Canberra Hospital - Garran
Fiona Stanley Hospital - Murdoch
Goulburn Valley Health - Shepparton campus - Shepparton
Port Macquarie Base Hospital - Port Macquarie
Monash Medical Centre - Clayton campus - Clayton
Nepean Hospital - Kingswood
Southwest Health Care - Warrnambool - Warrnambool
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Tamworth Rural Referral Hospital - Tamworth
The Tweed Hospital - Tweed Heads
Westmead Hospital - Westmead
Wollongong Hospital - Wollongong


Postcode
3011 - Footscray
3050 - Parkville
3052 - Parkville
3128 - Box Hill
3076 - Epping
3000 - Melbourne
3144 - Malvern
3550 - Bendigo
2290 - Gateshead
2298 - Waratah
2605 - Garran
6150 - Murdoch
3630 - Shepparton
2444 - Port Macquarie
3168 - Clayton
2747 - Kingswood
3280 - Warrnambool
3065 - Fitzroy
2340 - Tamworth
2485 - Tweed Heads
2145 - Westmead
2500 - Wollongong

Anticipated date of first participant enrolment4/12/2017

Anticipated date of last participant enrolment4/12/2017

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The primary purpose of this study is to show that by using ctDNA results, in addition to assessing the risk of tumour recurrence by standard pathology assessments, the number of patients receiving adjuvant (post surgery) chemotherapy will be reduced.
Who is it for?
You may be eligible to join this study if you are aged 18 or over, and have received chemo-radiation followed by surgery for locally advanced rectal cancer.
Study details:
All patients enrolled in this study are randomly allocated (by chance) to one of two groups; Standard of care (SOC) group or the ctDNA-informed group.  The decision to proceed with chemotherapy for those in the SOC group is based only on the standard risk assessment of the tumour (how likely your tumour is to come back or recur). Their ctDNA result will not be disclosed.  Those who are randomised to the ctDNA-informed group will be treated with chemotherapy if they are ctDNA positive OR if they are ctDNA negative AND are considered to have a tumour at high risk of recurring based on the standard risk assessment.  Only those in the ctDNA-informed group who have chemotherapy will have monthly ctDNA samples collected; up to four samples collected over 4 months then a final sample after chemotherapy has finished.
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.
It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision as to who receives adjuvant chemotherapy will result in a reduction in the number of patients having chemotherapy and doing so, without compromising the rate of disease recurrence when compared to standard of care.
Eligibility

Key inclusion criteria

1.	Aged  18 years of age and over
2.	Subjects with locally advanced rectal cancer treated with curative intent 
3.	Subjects treated with pre-operative long course chemo-radiation and surgery 
4.	CT scan of chest/abdomen/pelvis prior to commencing pre-operative chemo-radiation demonstrating no metastatic disease
5.	A tumour sample (from the pre-treatment biopsy or surgery specimen is available for molecular testing within 35 days after surgery
6.	Fit for adjuvant (post surgery) chemotherapy

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

1.	History of another primary cancer within the last 3 years (with the exception of non-melanoma skin cancer and carcinoma in situ).
2.	Patients with multiple primary colorectal cancers
3.	Inadequate bone marrow, kidney and liver function, as determined by blood tests
4.	Evidence of active infection
5.	Clinically significant cardiovascular disease
6.	Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the study requirements
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: AGITG
Primary Sponsor Address: GI Cancer Institute @ Lifehouse Level 6, 119-143 Missenden Rd Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12617001560381

UTNU1111-1204-7277

Contact person for information and recruitmentMs
Tina Cavicchiolo
The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade Parkville Victoria, 3052
+61 499250152
+61 3 9345 2317
Further information icontina.cavicchiolo@mh.org.au
Australia