None listed
Conditions
Brief summary
The primary purpose of this study is to show that by using ctDNA results, in addition to assessing the risk of tumour recurrence by standard pathology assessments, the number of patients receiving adjuvant (post surgery) chemotherapy will be reduced. Who is it for? You may be eligible to join this study if you are aged 18 or over, and have received chemo-radiation followed by surgery for locally advanced rectal cancer. Study details: All patients enrolled in this study are randomly allocated (by chance) to one of two groups; Standard of care (SOC) group or the ctDNA-informed group. The decision to proceed with chemotherapy for those in the SOC group is based only on the standard risk assessment of the tumour (how likely your tumour is to come back or recur). Their ctDNA result will not be disclosed. Those who are randomised to the ctDNA-informed group will be treated with chemotherapy if they are ctDNA positive OR if they are ctDNA negative AND are considered to have a tumour at high risk of recurring based on the standard risk assessment. Only those in the ctDNA-informed group who have chemotherapy will have monthly ctDNA samples collected; up to four samples collected over 4 months then a final sample after chemotherapy has finished. 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. It is hoped that the findings from this study will demonstrate that using ctDNA results to help make a decision as to who receives adjuvant chemotherapy will result in a reduction in the number of patients having chemotherapy and doing so, without compromising the rate of disease recurrence when compared to standard of care.
Interventions
The study involves blood collection for ctDNA analysis in patients with locally advanced rectal cancer who have undergone pre-operative long course chemo-radiation and surgery. Two ctDNA samples are collected initially in the outpatient setting; at weeks 4 and 7 post surgery. Patients are then randomised to either the standard of care (SOC) arm or the ctDNA-informed arm.
ctDNA-informed arm:
Patients who have either a positive ctDNA result OR a negative ctDNA result and have a tumour that i
The study involves blood collection for ctDNA analysis in patients with locally advanced rectal cancer who have undergone pre-operative long course chemo-radiation and surgery. Two ctDNA samples are collected initially in the outpatient setting; at weeks 4 and 7 post surgery. Patients are then randomised to either the standard of care (SOC) arm or the ctDNA-informed arm. ctDNA-informed arm: Patients who have either a positive ctDNA result OR a negative ctDNA result and have a tumour that is at high-risk of recurring (based on the standard pathology risk assessment of their tumour) will go on to have chemotherapy which will consist of 4 months of either 5FU or Capecitabine with or without Oxaliplatin. Up to a total of five ctDNA blood samples will be collected from each patient during (monthly) and at completion of chemotherapy. SOC arm; A decision regarding adjuvant chemotherapy will be based on the standard pathology risk assessment of their tumour. Chemotherapy will consist of 4 months of treatment with either 5FU or Capecitabine with or without Oxaliplatin. No further ctDNA samples will be collected in this group of patients. All patients will be follow up in the outpatient setting every 3 months for the first 2 years then every 6 months for 3 years out to 5 years in total. In the follow up period, a blood test for CEA (carcinoembryonic antigen; a tumour marker) will be collected at each visit. A CT scan will be done every 6 months for the first 2 years then at 3 years and thereafter only if clinically indicated.
Sponsors
AGITG
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 criteria
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
Outcome results
None listed