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

September 14, 2018 updated by: Royal Marsden NHS Foundation Trust

Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01323-903
        • Hospital Alemao Oswaldo Cruz
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • Cyprus
      • Nicosia, Cyprus
        • Bank Of Cyprus Oncology Centre
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital NHS Trust
      • Birmingham, United Kingdom, B18 7QH
        • Sandwell and West Birmingham Hospitals NHS Trust
      • Croydon, United Kingdom, CR7 7YE
        • Croydon University Hospital
      • London, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • Manchester, United Kingdom, M8 5RB
        • Pennine Acute Hospitals NHS Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden NHS Trust
    • Cambridgeshire
      • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
        • Hinchingbrooke Hospital
    • County Durham
      • Durham, County Durham, United Kingdom, DH1 5TW
        • County Durham and Darlington NHS Trust (University Hospital of North Durham)
      • Stockton-on-Tees, County Durham, United Kingdom, TS24 9AH
        • North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
    • Dorset
      • Dorchester, Dorset, United Kingdom, DT1 2JY
        • Dorset County Hospital Nhs Foundation Trust
      • Poole, Dorset, United Kingdom, BH15 2JB
        • Poole Hospital NHS Foundation Trust
    • Essex
      • Colchester, Essex, United Kingdom, CO3 3NB
        • Essex County Hospital
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
    • Kent
      • Gillingham, Kent, United Kingdom, ME7 5NY
        • Medway NHS Foundation Trust
    • Middlesex
      • Harrow, Middlesex, United Kingdom, HA1 3UJ
        • North West London Hospitals NHS Trust (Northwick Park Hospital)
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
        • James Paget University Hospitals NHS Foundation Trust
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • Epsom and St Helier's Hospitals NHS Trust
    • West Sussex
      • Chichester, West Sussex, United Kingdom, PO19 6SE
        • St Richard's Hospital
    • West Yorkshire
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Experimental: Group 2
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
Time Frame: 3 months
3 months
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
Time Frame: 3 months
3 months
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
Time Frame: 3 months
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
3 months
Local and distant recurrence rates.
Time Frame: 5 years
5 years
Radiotherapy related toxicity rates.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Diana Tait, Royal Marsden NHS Foundation Trust
  • Principal Investigator: Gina Brown, Royal Marsden Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2009

Primary Completion (Actual)

December 8, 2014

Study Completion (Anticipated)

December 8, 2019

Study Registration Dates

First Submitted

December 18, 2009

First Submitted That Met QC Criteria

December 18, 2009

First Posted (Estimate)

December 21, 2009

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR3227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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