Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks

Phase 2

• Conditions: Adenocarcinoma; Adenocarcinoma, Mucinous; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous; Digestive System Neoplasms; Intestinal Diseases; Carcinoma; Colorectal Neoplasms; Digestive System Diseases

• Registration Number: NCT01037049
• Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-16
• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-18
• Study First Posted: 2009-12-21
• Primary Completion: 2014-12-08
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-14
• Last Update Posted: 2018-09-17
• Study Completion: 2019-12-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 237

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Radiotherapy related toxicity rates.	5 years
Local and distant recurrence rates.	5 years

Trial Locations

Locations (23)

Hospital Alemão Oswaldo Cruz; 🇧🇷 Sao 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

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