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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | No Intervention | Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy | |
| Group 2 | Experimental | Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI]. | 6-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. | 3 months | |
| Difference in proportion of patients in each arm undergoing sphincter saving surgery. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Tait | Royal Marsden NHS Foundation Trust | Principal Investigator |
| Gina Brown | Royal Marsden Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Alemão Oswaldo Cruz | São Paulo | 01323-903 | Brazil | |||
| Jewish General Hospital |
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| Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. | 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. | 3 months |
| Local and distant recurrence rates. | 5 years |
| Radiotherapy related toxicity rates. | 5 years |
| Montreal |
| Quebec |
| H3T 1E2 |
| Canada |
| Bank of Cyprus Oncology Centre | Nicosia | Cyprus |
| Hinchingbrooke Hospital | Huntingdon | Cambridgeshire | PE29 6NT | United Kingdom |
| County Durham and Darlington NHS Trust (University Hospital of North Durham) | Durham | County Durham | DH1 5TW | United Kingdom |
| North Tees and Hartlepool NHS Trust (University Hospital of North Tees) | Stockton-on-Tees | County Durham | TS24 9AH | United Kingdom |
| Dorset County Hospital NHS Foundation Trust | Dorchester | Dorset | DT1 2JY | United Kingdom |
| Poole Hospital NHS Foundation Trust | Poole | Dorset | BH15 2JB | United Kingdom |
| Essex County Hospital | Colchester | Essex | CO3 3NB | United Kingdom |
| Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital) | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| Medway NHS Foundation Trust | Gillingham | Kent | ME7 5NY | United Kingdom |
| North West London Hospitals NHS Trust (Northwick Park Hospital) | Harrow | Middlesex | HA1 3UJ | United Kingdom |
| James Paget University Hospitals NHS Foundation Trust | Great Yarmouth | Norfolk | NR31 6LA | United Kingdom |
| Epsom and St Helier's Hospitals NHS Trust | Carshalton | Surrey | SM5 1AA | United Kingdom |
| St Richard's Hospital | Chichester | West Sussex | PO19 6SE | United Kingdom |
| Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital) | Wakefield | West Yorkshire | WF1 4DG | United Kingdom |
| Royal United Hospital NHS Trust | Bath | BA1 3NG | United Kingdom |
| Sandwell and West Birmingham Hospitals NHS Trust | Birmingham | B18 7QH | United Kingdom |
| Croydon University Hospital | Croydon | CR7 7YE | United Kingdom |
| St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| St George's Healthcare NHS Trust | London | SW17 0QT | United Kingdom |
| Pennine Acute Hospitals NHS Trust | Manchester | M8 5RB | United Kingdom |
| Royal Marsden NHS Trust | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| D002288 | Adenocarcinoma, Mucinous |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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