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

Sponsor

Royal Marsden NHS Foundation Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT01037049

Collaborator

(none)

237

Enrollment

Locations

Arms

121.7

Anticipated Duration (Months)

10.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

237 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 16, 2009

Actual Primary Completion Date :

Dec 8, 2014

Anticipated Study Completion Date :

Dec 8, 2019

Arms and Interventions

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

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

Outcome Measures

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]. [6-12 weeks]

Secondary Outcome Measures

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]
Local and distant recurrence rates. [5 years]
Radiotherapy related toxicity rates. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

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

Sponsors and Collaborators

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