None listed
Conditions
Brief summary
Circulating Tumour DNA as a marker of complete athological response and long term outcome for locally advanced rectal cancer treated with pre-operative chemoradiotherapy. The aim of the study is to demonstrate that the eradication of ctDNA in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer
Interventions
This is an exploratory prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with locally advanced
rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. Patients will be treated and followed according to standard
practice.The collection of serial blood samples at specifed timepoints. The timepoints are as follows Timepoint 1 baseline (prior to chemo radiation), timepoin
This is an exploratory prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from patients with locally advanced rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy. Patients will be treated and followed according to standard practice.The collection of serial blood samples at specifed timepoints. The timepoints are as follows Timepoint 1 baseline (prior to chemo radiation), timepoint 2 4 – 6 weeks post chemo-radiation and the final timepoint (timepoint 3)being 4 – 10 weeks post surgery. For this study there are three timepoints for blood collection and at each time point 60mls of blood will be collected. Each patient’s treating surgeon will assess and document the clinical response to CRT prior to surgery. Resected tumour samples will be made available after surgery for mutation analysis. If there is no or minimal residual disease in the resected specimen, then the preoperative diagnostic biopsy will be used. Histology slides will be made available for central assessment of pathological response to chemoradiation. Follow-up will be as per standard practice, including 3-monthly CEA and annual CT chest/abdomen/pelvis for at least 2 years.
Sponsors
Ludwig Institute for Cancer Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically confirmed adenocarcinoma of the rectum 2. Patients with radiologically defined locally advanced disease on pelvic MRI (mT3, mT4 or mN+) or endorectal ultrasound (uT3, uT4 or uN1) where MRI is contraindicated) 3. No evidence of metastatic disease on CT chest/abdomen/pelvis 4. Patients planned to receive long-course chemoradiation followed by curative surgery and adjuvant 5-fluorouracil or capecitabine chemotherapy 5. Patients willing to provide written informed consent
Exclusion criteria
1. History of another primary cancer within the last 5 years, with the exception of nonmelanomatous skin cancer and carcinoma in situ of the cervix. 2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol 3. Patients with major organ impairment 4. Patients that are not accessible for follow-up
Outcome results
None listed