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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

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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.

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