Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks
NCT ID: NCT01037049
Last Updated: 2018-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
237 participants
INTERVENTIONAL
2009-10-16
2019-12-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Group 1
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
No interventions assigned to this group
Group 2
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Interventions
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Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Eligibility Criteria
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Inclusion Criteria
* Informed written consent
* Histological confirmation of adenocarcinoma of rectum
* Undergoing pre-operative radiotherapy/ chemotherapy
* Completion of pre-operative treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Diana Tait
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Gina Brown
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden Hospitals NHS Foundation Trust
Locations
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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
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom
North West London Hospitals NHS Trust (Northwick Park Hospital)
Harrow, Middlesex, United Kingdom
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, United Kingdom
Epsom and St Helier's Hospitals NHS Trust
Carshalton, Surrey, United Kingdom
St Richard's Hospital
Chichester, West Sussex, United Kingdom
Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)
Wakefield, West Yorkshire, United Kingdom
Royal United Hospital NHS Trust
Bath, , United Kingdom
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, , United Kingdom
Croydon University Hospital
Croydon, , 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
Royal Marsden NHS Trust
Sutton, , United Kingdom
Countries
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Other Identifiers
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CCR3227
Identifier Type: -
Identifier Source: org_study_id
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