Trial purpose
Cancer treatment
Tumor type
Lower gastrointestinal tract
Age
18+
Trial acronym
Dynamic-Rectal
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 people with Rectal Cancer
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
- Your cancer has not spread to other parts of the body (localised).
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
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
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