InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 12 February 2024

DYNAMIC-II: This study is looking at circulating DNA and how it could inform adjuvant chemotherapy for recurrence-free survival in patient with stage II colon cancerCirculating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

Clinical summary

Summary

This study will determine the effect of the use of circulating tumour DNA (ctDNA) to guide adjuvant chemotherapy on recurrence-free survival in stage II colon or rectal cancer patients Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with Stage II colon or rectal cancer and have had your cancer curatively resected. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have blood samples taken and analysed for circulating tumour DNA (ctDNA) and be treated according to the ctDNA results. Those with positive ctDNA results will receive standard 5FU-based adjuvant chemotherapy, while those with negative ctDNA will not receive adjuvant chemotherapy. Participants in the other group will have a blood sample taken, but the ctDNA result will not be disclosed. Patients in this group will be treated according to standard clinical criteria at the discretion of the treating physician. Participants who had positive ctDNA results and are being treated with adjuvant chemotherapy will have monthly blood samples taken during treatment to track ctDNA levels. 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.

Conditions

This trial is treating patients with Colon and Rectum Cancer

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18 - 75

Phase

Not applicable

Trial Acronym

DYNAMIC-II

More information

Trial Identifiers

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

Trial sponsor

Walter and Eliza Hall Institute

Scientific Title

Circulating tumour DNA (ctDNA) analysis informing adjuvant chemotherapy in Stage II Colon Cancer

Eligibility

Inclusion

1. Subjects with curatively resected stage II (T3-4, N0M0) colon or rectal cancer.
2. Patients with rectal cancer will be eligible unless they have had pre-operative combined chemotherapy or radiotherapy, or are scheduled for post-operative combined chemotherapy and radiotherapy. All rectal cancer patients included in the trial must have had TME type surgery with negative (R0) resection margins.
3. A representative paraffin embedded tumour sample is avaiable for molecular testing.
4. Fit for adjuvant chemotherapy.
5. ECOG performance status 0-2.
6. Patients that are accessible for follow up.
7. CT C/A/P within 8 weeks demonstrating no metastatic disease.

Exclusion

1. History of another primary cancer within the last 3 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix.
2. Patients with multiple primary colorectal cancers
3. Patients treated with neoadjuvant chemo-radiation.
4. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

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.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.