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

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel

Systemic therapy,Treatment | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase II/III trial is evaluating the process of using ctDNA (tumour-derived DNA) results as a way to tailor treatment (in this case chemotherapy) in patients with stage III colon cancer .

This trial is treating patients with colon cancer.

This is a systemic therapy trial .

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Other Non-Commercial Sponsor

Walter and Eliza Hall Institute


This is a prospective multi-centre, phase II/III randomised controlled study enrolling a total of 1000 stage III colon cancer patients. Patients will be randomised 1:1 to be treated according to post-op ctDNA results (Arm B: ctDNA-informed), or per standard of care (Arm A: SOC). Enrolment will be stratified by participating centre and clinical risk groups (low risk = T1-3N1; high risk = T4 and/or N2). Patients should be screened within 21 days after surgery and tumour samples will be made available in 3 working days from consent for mutation analysis. All patients will have a blood draw during week 5-6 post-op for ctDNA analysis (ctDNA-1: post-op day 32 to day 42). Clinicians are to nominate their standard of care adjuvant chemotherapy regimen (no chemotherapy, single agent fluoropyrimidine or combination fluropyrimidine plus oxaliplatin) at the time of enrolment prior to randomisation. Randomisation will occur after the post-op ctDNA blood draw. Additional blood collection time-points will depend on the schedule of adjuvant chemotherapy. Formalin-fixed paraffin embedded tumour tissue and the study bloods sample will undergo ctDNA analysis at Johns Hopkins University. In the ctDNA-informed arm (Arm B), the post-op ctDNA result will be made available to the treating clinician within 8 weeks post-op. Adjuvant chemotherapy will commence after the ctDNA result becomes available or, where the treating clinician wishes to commence adjuvant treatment before the result is available, an individual patient may commence on standard of care treatment no earlier than 6 weeks post-op, and then switch to the ctDNA informed strategy as per the protocol. Patients who are "ctDNA negative" will be managed with a de-escalation adjuvant treatment strategy and those who are "ctDNA-positive" will be managed with an escalation adjuvant treatment strategy. In the standard of care arm, patients and their clinicians will be blinded to the ctDNA results and will receive adjuvant chemotherapy as per standard of care. Patients in Arm B receiving 3 or 6 months of adjuvant chemotherapy will have blood collection for ctDNA analysis during treatment (ctDNA-2A +/- ctDNA-2B) and at the end of treatment (ctDNA-3). These results will not be routinely made available to the patients or clinicians. For patients where standard treatment of oxaliplatin based treatment is escalated to FOLFOXIRI, this will be given for at least 6 cycles.

Recruiting Hospitals Read MoreRead more

Ballarat Hospital
Ms Carmel Goss
03 5320 4735

Bendigo Hospital
Ms Amanda Rundle
03 5454 8821

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
03 9094 9544

Peninsula Health
Mr Nathan Dorembus
03 9784 8562

Goulburn Valley Health
Ms Carole Mott
(03) 5832 3777

PCCTU (Parkville Cancer Clinical Trials Unit) *
Enquiries Line Coordinator
03 8559 7456 (9am-2pm, Mon-Fri)

St Vincent's Hospital, Medical and Radiation Oncology
Ms Nadia Ranieri
03 9231 3167

South West Healthcare
Kaye McDowall

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Recruitment on hold

Northern Hospital
Lynda Harrison
03 8405 8715


Monash Health, Medical Oncology
GI Research Study Coordinator

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.