se of circulating tumour DNA (ctDNA) results to inform the decision for adjuvant chemotherapy in patients with locally advanced rectal cancer who have been treated with pre-operative chemo-radiation and surgery.

Not Applicable

• Conditions: ocally advanced rectal cancer treated with pre-operative long course chemo-radiation and surgery; Locally advanced rectal cancer treated with pre-operative long course chemo-radiation and surgery; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12617001560381
• Lead Sponsor: AGITG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-15
• Last Update Posted: 27 December 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified