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: 20 February 2024

Dynamic-Rectal: This trial is evaluating the process of using tumour-derived DNA (ctDNA) results as a way of tailoring treatment (in this case, chemotherapy) for patients with locally advanced rectal cancerCirculating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study

Clinical summary

Summary

This trial will involve collecting blood for a ctDNA analysis in patients with locally advanced rectal cancer who have undergone pre-operative long course chemo-radiation and surgery. Based on the results of the ctDNA analysis, patients will be randomized into one of two arms. In the ctDNA-informed arm, participants will receive chemotherapy which will consist of either either 5FU or Capecitabine with or without Oxaliplatin, based on a positive ctDNA or negative ctDNA result. In the standard of care (SOC) arm, participants will receive chemotherapy based on a standard pathology risk assessment of their cancer.

Conditions

This trial is treating patients with Rectal Cancer.

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

Not applicable

Trial Acronym

Dynamic-Rectal

More information

Trial Identifiers

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

Trial sponsor

National Health & Medical Research Council (NHMRC),Australasian Gastro-Intestinal Trials Group (AGITG)

Scientific Title

Circulating Tumour DNA Analysis Informing Adjuvant Chemotherapy in Locally Advanced Rectal Cancer: A Multicentre Randomised Study

Eligibility

Inclusion

 1. Aged 18 years of age and over
2. Subjects with locally advanced rectal cancer treated with curative intent
3. Subjects treated with pre-operative long course chemo-radiation and surgery
4. CT scan of chest/abdomen/pelvis prior to commencing pre-operative chemo-radiation demonstrating no metastatic disease
5. A tumour sample (from the pre-treatment biopsy or surgery specimen is available for molecular testing within 35 days after surgery
6. Fit for adjuvant (post surgery) chemotherapy

Exclusion

 1. History of another primary cancer within the last 3 years (with the exception of non-melanoma skin cancer and carcinoma in situ).
2. Patients with multiple primary colorectal cancers
3. Inadequate bone marrow, kidney and liver function, as determined by blood tests
4. Evidence of active infection
5. Clinically significant cardiovascular disease
6. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the study requirements

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • 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.
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

Speak with someone who has cancer clinical trial 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

CloseReport inaccuracy

Thank you for helping us to increase accuracy of the trial. Our team will validate the information and update the information as soon as possible.

Submitting ... Please wait

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.