Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

Status: Recruiting
Location: See all (71) locations...
Study Type: Observational
SUMMARY

TRACC Part B This is a multi-centre, prospective, translational research study involving the collection and analysis of tumour tissue, serial blood samples and clinical data in patients with newly diagnosed stage I, II and III CRC. TRACC Part C is a : (multi-centre, prospective, randomised study, of ctDNA guided adjuvant chemotherapy versus standard of care adjuvant chemotherapy study after curative surgery in patients with high risk stage II or stage III CRC. )It aims to demonstrate that a de-escalation strategy of ctDNA guided adjuvant chemotherapy is non- inferior to standard of care treatment as measured by 3 year disease free survival (DFS) in patients with high risk stage II or stage III colorectal cancer CRC with no evidence of minimal residual disease (MRD) (ctDNA negative)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject ≥ 18 years of age

• Subjects with histologically proven high risk stage II or stage III colon or rectal cancer treated with curative intent with surgery alone (any T, N1 or N2) with no evidence of metastatic disease. High risk stage II is defined as having one or more of the following: T4 disease, obstruction and/or perforation of the primary tumour during the pre-operative period, inadequate nodal harvest as indicated by \<12 nodes examined, poorly differentiated grade on histology, perineural invasion, peritoneal involvement or extramural venous/lymphatic invasion. Subjects must be due to receive adjuvant chemotherapy after surgery or Subjects with histologically proven locally advanced stage III rectal cancer treated with neoadjuvant chemoradiotherapy (any T, N1 or N2, M0) with no evidence of metastatic disease are eligible. Subjects must be due to receive adjuvant chemotherapy after surgery

• Fully surgically resected tumour with clear resection margins (i.e., \>1 mm).

• Adequate organ function

‣ Absolute neutrophil function ≥1.0 x 109/ L

⁃ Platelet Count ≥ 75 x 109 / L

⁃ Haemoglobin ≥80g/L (blood transfusion before randomisation is allowed)

⁃ Adequate renal function (GFR ≥ 50ml/min if single agent capecitabine or CAPOX being administered) as calculated by Cockcroft and Gault equation

⁃ Aspartate aminotransferase/ Alanine aminotransferase levels ≤ 2.5 upper limit of normal

• Absence of major post-operative complications or other clinical conditions that, in the opinion of the investigator, would contraindicate adjuvant chemotherapy

• Patients should be assessed by Oncology team for suitability and assessment for adjuvant chemotherapy, be able to have post-operative ctDNA sample collected and be randomised by week 8 ± 2 weeks after surgery.

• ECOG performance status 0- 2

• Able to give informed consent

Locations
Other Locations
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Bronglais Hospital
RECRUITING
Aberystwyth
Stoke Mandeville Hospital
RECRUITING
Aylesbury
Basildon and Thurrock University Hospitals
RECRUITING
Basildon
Basingstoke and North Hampshire Hospitals
RECRUITING
Basingstoke
Bedford Hospital
RECRUITING
Bedford
Royal Blackburn Teaching Hospital
RECRUITING
Blackburn
Pilgrim Hospital
RECRUITING
Boston
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Bradford Royal Infirmary
RECRUITING
Bradford
University Hospitals Bristol NHS Foundation Trust
RECRUITING
Bristol
Burnley General Teaching Hospital
RECRUITING
Burnley
West Suffolk Hospital
RECRUITING
Bury
Addenbrookes Hospital
RECRUITING
Cambridge
Kent and Canterbury Hospital
RECRUITING
Canterbury
North Cumbria University Hospitals
RECRUITING
Carlisle
Glangwili Hospital
RECRUITING
Carmarthen
Epsom and St Helier's Hospitals NHS Trust
ACTIVE_NOT_RECRUITING
Carshalton
Broomfield Hospital
RECRUITING
Chelmsford
Castle Hill Hospital
RECRUITING
Cottingham
University Hospitals Coventry & Warwickshire
RECRUITING
Coventry
Leighton Hospital
RECRUITING
Crewe
University Hospital Crosshouse
RECRUITING
Crosshouse
Dorset County Hospital NHS Foundation Trust
RECRUITING
Dorchester
Medway NHS Foundation Trust
ACTIVE_NOT_RECRUITING
Gillingham
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
The Princess Alexandra Hospital NHS Trust
RECRUITING
Harlow
Withybush General Hospital
RECRUITING
Haverfordwest
Wycombe Hospital
RECRUITING
High Wycombe
Calderdale and Huddersfield NHS Foundation Trust
RECRUITING
Huddersfield
Airedale General Hospital
RECRUITING
Keighley
Kettering General Hospital
RECRUITING
Kettering
Kingston Hospital Foundation Trust
RECRUITING
Kingston Upon Thames
Forth Valley Royal Hospital
RECRUITING
Larbert
St James's University Hospital
RECRUITING
Leeds
Lincoln County Hospital
RECRUITING
Lincoln
Prince Philip Hospital
RECRUITING
Llanelli
Barts Health NHS Trust
RECRUITING
London
Chelsea and Westminster
ACTIVE_NOT_RECRUITING
London
Guy's & St Thomas Hospital
RECRUITING
London
North Middlesex University Hospital NHS Trust
RECRUITING
London
Royal Free Hospital
RECRUITING
London
St George's NHS Foundation Trust
ACTIVE_NOT_RECRUITING
London
The Royal Marsden NHS Foundation Trust - London
RECRUITING
London
Maidstone & Tunbridge Wells NHS Trust
RECRUITING
Maidstone
Christie NHS Foundation Trust
RECRUITING
Manchester
Chase Farm Hospital
RECRUITING
Middlesex
Milton Keynes General Hospital
RECRUITING
Milton Keynes
Northampton General Hospital NHS Trust
RECRUITING
Northampton
Nottingham University Hospital
ACTIVE_NOT_RECRUITING
Nottingham
George Eliot Hospital
RECRUITING
Nuneaton
Poole Hospital
RECRUITING
Poole
Queen Alexandra Hospital
RECRUITING
Portsmouth
Royal Preston Hospital, Lancashire Teaching Hospitals
RECRUITING
Preston
Barking Havering and Redbridge NHS Foundation Trust (Queen's Hospital
RECRUITING
Romford
Salisbury District Hospital
RECRUITING
Salisbury
Weston Park Hospital
RECRUITING
Sheffield
Royal Shrewsbury Hospital
RECRUITING
Shrewsbury
South Tyneside District Hospital
RECRUITING
South Shields
University Hospital Southampton
RECRUITING
Southampton
Stockport NHS Foundation Trust
RECRUITING
Stockport
Sunderland Royal Hospital
RECRUITING
Sunderland
The Royal Marsden NHS Foundation Trust
RECRUITING
Sutton
King's Mill Hospital
RECRUITING
Sutton In Ashfield
Singleton Hospital
RECRUITING
Swansea
Musgrove Park Hospital
RECRUITING
Taunton
Croydon University Hospital
RECRUITING
Thornton Heath
Weston General Hospital
RECRUITING
Weston-super-mare
Wrightington, Wigan and Leigh NHS Foundation Trust
RECRUITING
Wigan
Royal Hampshire County Hospital
RECRUITING
Winchester
University Hospital of South Manchester & Manchester Royal Infirmary
RECRUITING
Wythenshawe
Contact Information
Primary
Hsiang-Chi Chen, MSc
TRACCStudy@rmh.nhs.uk
02086426011
Backup
Susie Slater, Dr
Time Frame
Start Date: 2016-12-05
Estimated Completion Date: 2031-07-31
Participants
Target number of participants: 1000
Treatments
Part B TRACC Colon
Patients with diagnosis of large bowel cancer (in the colon) and no evidence of metastatic disease
Part B TRACC Rectal
Patients who have a diagnosis of large bowel cancer (in the Rectum) and no evidence of metastatic disease
Part C TRACC- Standard of Care Adjuvant Chemotherapy
Randomised to Arm A: Standard of Care Arm (Patients with fully resected high risk stage II or stage III colon or Rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol.
Part C-ct DNA Guided Arm
Patients with fully resected high risk stage II or stage III colon or rectal cancer with no evidence of metastatic disease. Patients with locally advanced rectal cancer who have previously undergone chemoradiotherapy are also eligible to enrol.~De-escalation of adjuvant chemotherapy in patients who have a post-operative ctDNA negative result
Related Therapeutic Areas
Sponsors
Leads: Royal Marsden NHS Foundation Trust

This content was sourced from clinicaltrials.gov