Neoplasms Clinical Trial
Official title:
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
Verified date | September 2018 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 237 |
Est. completion date | December 8, 2019 |
Est. primary completion date | December 8, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Aged > 18 - Informed written consent - Histological confirmation of adenocarcinoma of rectum - Undergoing pre-operative radiotherapy/ chemotherapy - Completion of pre-operative treatment Exclusion Criteria: - Aged < 18 - Absence of pre-operative RT/CT - Medical/ psychiatric conditions that compromise the patients ability to give informed consent - Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Alemão Oswaldo Cruz | Sao Paulo | |
Canada | Jewish General Hospital | Montreal | Quebec |
Cyprus | Bank of Cyprus Oncology Centre | Nicosia | |
United Kingdom | Royal United Hospital NHS Trust | Bath | |
United Kingdom | Sandwell and West Birmingham Hospitals NHS Trust | Birmingham | |
United Kingdom | Epsom and St Helier's Hospitals NHS Trust | Carshalton | Surrey |
United Kingdom | St Richard's Hospital | Chichester | West Sussex |
United Kingdom | Essex County Hospital | Colchester | Essex |
United Kingdom | Croydon University Hospital | Croydon | |
United Kingdom | Dorset County Hospital NHS Foundation Trust | Dorchester | Dorset |
United Kingdom | County Durham and Darlington NHS Trust (University Hospital of North Durham) | Durham | County Durham |
United Kingdom | Medway NHS Foundation Trust | Gillingham | Kent |
United Kingdom | James Paget University Hospitals NHS Foundation Trust | Great Yarmouth | Norfolk |
United Kingdom | North West London Hospitals NHS Trust (Northwick Park Hospital) | Harrow | Middlesex |
United Kingdom | Hinchingbrooke Hospital | Huntingdon | Cambridgeshire |
United Kingdom | St Bartholomew's Hospital | London | |
United Kingdom | St George's Healthcare NHS Trust | London | |
United Kingdom | Pennine Acute Hospitals NHS Trust | Manchester | |
United Kingdom | Poole Hospital NHS Foundation Trust | Poole | Dorset |
United Kingdom | Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital) | Portsmouth | Hampshire |
United Kingdom | North Tees and Hartlepool NHS Trust (University Hospital of North Tees) | Stockton-on-Tees | County Durham |
United Kingdom | Royal Marsden NHS Trust | Sutton | |
United Kingdom | Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital) | Wakefield | West Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
Brazil, Canada, Cyprus, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | ||
Secondary | Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. | 3 months | ||
Secondary | Difference in proportion of patients in each arm undergoing sphincter saving surgery. | 3 months | ||
Secondary | Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. | 3 months | ||
Secondary | 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 | ||
Secondary | Local and distant recurrence rates. | 5 years | ||
Secondary | Radiotherapy related toxicity rates. | 5 years |
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