The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
237
Hospital Alemão Oswaldo Cruz
São Paulo, Brazil
Jewish General Hospital
Montreal, Quebec, Canada
Bank of Cyprus Oncology Centre
Nicosia, Cyprus
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, United Kingdom
County Durham and Darlington NHS Trust (University Hospital of North Durham)
Durham, County Durham, United Kingdom
North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
Stockton-on-Tees, County Durham, United Kingdom
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom
Poole Hospital NHS Foundation Trust
Poole, Dorset, United Kingdom
Essex County Hospital
Colchester, Essex, United Kingdom
Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
Portsmouth, Hampshire, United Kingdom
...and 13 more locations
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
Time frame: 6-12 weeks
Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
Time frame: 3 months
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
Time frame: 3 months
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
Time frame: 3 months
An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms.
Time frame: 3 months
Local and distant recurrence rates.
Time frame: 5 years
Radiotherapy related toxicity rates.
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.