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
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

Two/ThreePhase Two/Three

18+Age Over 18

Bowel<br/>CancersCancer LocationBowel
Cancers

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

Summary

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
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

Bendigo Hospital
Bendigo
Ms Amanda Rundle
arundle@bendigohealth.org.au
03 5454 8821

St Vincent's Hospital, Medical and Radiation Oncology
Fitzroy
Ms Nadia Ranieri
oncology.research@svha.org.au
03 9288 3167

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Not Recruiting Hospitals Read MoreRead more

Not currently recruiting

Warrnambool Hospital
Warrnambool
Sandra Robinson
sjrobinson@swh.net.au
03 5562 9056

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.

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