Clinical Trial Details

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Stage III Colon Cancer: A Multicentre Phase II/III Randomised Controlled Study (DYNAMIC-III)

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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
NSW,NT,QLD,SA,TAS,WA,VIC

Hospital
Royal Melbourne Hospital - City campus - Parkville
Western Private Hospital - Footscray
Box Hill Hospital - Box Hill
The Northern Hospital - Epping
Port Macquarie Base Hospital - Port Macquarie
Wollongong Hospital - Wollongong
Flinders Medical Centre - Bedford Park
The Queen Elizabeth Hospital - Woodville
Royal Brisbane & Womens Hospital - Herston
Fiona Stanley Hospital - Murdoch
Newcastle Private Hospital - New Lambton Heights
Western Hospital - Footscray - Footscray
Peter MacCallum Cancer Centre - Melbourne
Melbourne Private Hospital - Parkville
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Southwest Health Care - Warrnambool - Warrnambool
Frankston Hospital - Frankston
Ballarat Health Services (Base Hospital) - Ballarat Central
Royal Hobart Hospital - Hobart
Lake Macquarie Private Hospital - Gateshead
Campbelltown Hospital - Campbelltown
Concord Repatriation Hospital - Concord
Liverpool Hospital - Liverpool
Northern Cancer Institute - St Leonards
Goulburn Valley Health - Shepparton campus - Shepparton
The Tweed Hospital - Tweed Heads
Tamworth Rural Referral Hospital - Tamworth
Macquarie University Hospital - Macquarie Park
Gosford Hospital - Gosford
Wyong Public Hospital - Hamlyn Terrace
Echuca Regional Health - Echuca
Nepean Hospital - Kingswood
Epworth Eastern Hospital - Box Hill
Epworth Freemasons (Victoria Parade) - East Melbourne
Epworth Richmond - Richmond
Peninsula Private Hospital - Frankston - Frankston
Katherine Hospital - Katherine
Royal Darwin Hospital - Tiwi


Postcode
3050 - Parkville
3011 - Footscray
3128 - Box Hill
3076 - Epping
2444 - Port Macquarie
2500 - Wollongong
5042 - Bedford Park
5011 - Woodville
4029 - Herston
6150 - Murdoch
2305 - New Lambton Heights
3000 - Melbourne
3052 - Parkville
3065 - Fitzroy
3550 - Bendigo
3280 - Warrnambool
3199 - Frankston
3350 - Ballarat Central
7000 - Hobart
2290 - Gateshead
2560 - Campbelltown
2139 - Concord
2170 - Liverpool
2065 - St Leonards
3630 - Shepparton
2485 - Tweed Heads
2340 - Tamworth
2109 - Macquarie Park
2250 - Gosford
2259 - Hamlyn Terrace
3564 - Echuca
2747 - Kingswood
3128 - Box Hill
3002 - East Melbourne
3121 - Richmond
3199 - Frankston
0850 - Katherine
0810 - Tiwi


Trial location outside Australia
New ZealandChristchurch

Phase of TrialPhase 2 / Phase 3

Has the study received ethics approval?Further information iconApproved

Trial summary

The aim of this study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer. 

Who is it for?
You may be eligible to join this study if you are aged 18 years or more and have undergone curative surgery for stage III colon cancer.

Study details
All participants in this study will have a blood draw during week 5-6 post surgery for ctDNA analysis. They will then be randomly allocated to one of two treatment groups. One group will receive standard of care treatment as selected by their clinician: either no chemotherapy, single agent fluoropyrimidine chemotherapy or combination fluoropyrimidine plus oxaliplatin chemotherapy. Treatment selection in the other group will be informed by ctDNA blood test results. 

All patients will be followed up every 3 months for 2 years, then every 6 months for 3 years in order to evaluate treatment safety and efficacy. Follow-up involves additional blood tests and radiological assessments. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision regarding adjuvant chemotherapy is not inferior to standard of care in terms of recurrence-free survival.
Eligibility

Key inclusion criteria

1.	Patients aged greater than or equal to 18 years of age
2.	Subjects with curatively resected stage III (Any T, N1 or N2, M0) colon cancer
3.	Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy and radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy.
4.	A representative tumour sample is available for molecular testing up to 6 weeks after surgery
5.	Fit for at least 3 months of fluoropyrimidine adjuvant chemotherapy
6.	ECOG performance status 0-2

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-melanomatous skin cancer and carcinoma in situ
2.	Patients with multiple primary colorectal cancers
3.	Inadequate organ function:
a.	Moderate/severe renal impairment (GFR<30 ml/min), as calculated by the Cockcroft and Gault equation
b.	Absolute neutrophil count <1.0x109/L
c.	Platelet count <75x109/L
d.	Haemoglobin <80 g/L
e.	 Aspartate aminotransferase/Alanine aminotransferase >2.5 x upper limit of normal
4.	Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
Contact details and further information

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

Trial websitenone

Trial IDACTRN12617001566325

UTNU1111-1204-7664

Contact person for information and recruitmentDr
Marlyse Debrincat
The Walter and Eliza Hall Institute of Medical Research 1G Royal Parade Parkville VIC 3052
+61 3 9345 2895
+61 3 9498 2010
Further information iconmarlyse.debrincat@mh.org.au
Australia