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Closed (no longer recruiting)Last updated: 8 February 2024

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

Clinical summary

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.

Conditions

This trial is treating patients with colon cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

II/III

Trial Acronym

DYNAMIC-III

More information

Trial Identifiers

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Trial sponsor

Walter and Eliza Hall Institute

Scientific Title

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

Eligibility

Inclusion

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

Exclusion

 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

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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