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

Primary Purpose

Adenocarcinoma of the Rectum, Adenocarcinoma, Adenocarcinoma, Mucinous

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adenocarcinoma of the Rectum focused on measuring Rectal Cancer, 6vs12, 6 vs 12, Cancer, CRM, Circumferential Resection Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology, Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Alemão Oswaldo Cruz
  • Jewish General Hospital
  • Bank of Cyprus Oncology Centre
  • Hinchingbrooke Hospital
  • County Durham and Darlington NHS Trust (University Hospital of North Durham)
  • North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
  • Dorset County Hospital NHS Foundation Trust
  • Poole Hospital NHS Foundation Trust
  • Essex County Hospital
  • Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
  • Medway NHS Foundation Trust
  • North West London Hospitals NHS Trust (Northwick Park Hospital)
  • James Paget University Hospitals NHS Foundation Trust
  • Epsom and St Helier's Hospitals NHS Trust
  • St Richard's Hospital
  • Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)
  • Royal United Hospital NHS Trust
  • Sandwell and West Birmingham Hospitals NHS Trust
  • Croydon University Hospital
  • St Bartholomew's Hospital
  • St George's Healthcare NHS Trust
  • Pennine Acute Hospitals NHS Trust
  • Royal Marsden NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Arm Description

Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy

Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Outcomes

Primary Outcome Measures

The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].

Secondary Outcome Measures

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

Full Information

First Posted
December 18, 2009
Last Updated
September 14, 2018
Sponsor
Royal Marsden NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01037049
Brief Title
Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks
Official Title
Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2009 (Actual)
Primary Completion Date
December 8, 2014 (Actual)
Study Completion Date
December 8, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma of the Rectum, Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Cystic, Mucinous, and Serous, Colorectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms by Site, Digestive System Diseases, Gastrointestinal Diseases, Intestinal Diseases, Rectal Diseases
Keywords
Rectal Cancer, 6vs12, 6 vs 12, Cancer, CRM, Circumferential Resection Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology, Radiotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Intervention Type
Other
Intervention Name(s)
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
Time Frame
3 months
Title
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
Time Frame
3 months
Title
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
Time Frame
3 months
Title
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
Title
Local and distant recurrence rates.
Time Frame
5 years
Title
Radiotherapy related toxicity rates.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Tait
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gina Brown
Organizational Affiliation
Royal Marsden Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Alemão Oswaldo Cruz
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Bank of Cyprus Oncology Centre
City
Nicosia
Country
Cyprus
Facility Name
Hinchingbrooke Hospital
City
Huntingdon
State/Province
Cambridgeshire
ZIP/Postal Code
PE29 6NT
Country
United Kingdom
Facility Name
County Durham and Darlington NHS Trust (University Hospital of North Durham)
City
Durham
State/Province
County Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
City
Stockton-on-Tees
State/Province
County Durham
ZIP/Postal Code
TS24 9AH
Country
United Kingdom
Facility Name
Dorset County Hospital NHS Foundation Trust
City
Dorchester
State/Province
Dorset
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Poole Hospital NHS Foundation Trust
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO3 3NB
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Medway NHS Foundation Trust
City
Gillingham
State/Province
Kent
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
Facility Name
North West London Hospitals NHS Trust (Northwick Park Hospital)
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
James Paget University Hospitals NHS Foundation Trust
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
Facility Name
Epsom and St Helier's Hospitals NHS Trust
City
Carshalton
State/Province
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
St Richard's Hospital
City
Chichester
State/Province
West Sussex
ZIP/Postal Code
PO19 6SE
Country
United Kingdom
Facility Name
Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)
City
Wakefield
State/Province
West Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
Royal United Hospital NHS Trust
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Sandwell and West Birmingham Hospitals NHS Trust
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Croydon University Hospital
City
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
St George's Healthcare NHS Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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