Circulating Tumour DNA as a Marker of Complete Pathological Response and Long Term Outcome for Locally Advanced Rectal Cancer Treated with Pre-operative Chemoradiotherapy

Not Applicable

• Conditions: Patients with locally advanced rectal cancer planned for pre-operative CRT followed by definitive surgery and post operative chemotherapy.; Nil; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12612000327886
• Lead Sponsor: udwig Institute for Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate that the eradication of circulating tumour DNA (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.[Analysis of blood/plasma and tissue samples collected throughout the study. Timepoint 1 baseline (prior to chemo radiation), timepoint 2 is 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.]