Clinical trial NCT01037049: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: 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
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-12-21
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
timeFrame: 6-12 weeks
Secondary outcomes:
measure: Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
timeFrame: 3 months
measure: Difference in proportion of patients in each arm undergoing sphincter saving surgery.
timeFrame: 3 months
measure: Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
timeFrame: 3 months
measure: 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.
timeFrame: 3 months
measure: Local and distant recurrence rates.
timeFrame: 5 years
measure: Radiotherapy related toxicity rates.
timeFrame: 5 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Nicosia
country: Cyprus
facility: Bank of Cyprus Oncology Centre
city: Huntingdon
country: United Kingdom
facility: Hinchingbrooke Hospital
state: Cambridgeshire
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Trust (University Hospital of North Durham)
state: County Durham
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
state: County Durham
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital NHS Foundation Trust
state: Dorset
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Foundation Trust
state: Dorset
city: Colchester
country: United Kingdom
facility: Essex County Hospital
state: Essex
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
state: Hampshire
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
state: Kent
city: Harrow
country: United Kingdom
facility: North West London Hospitals NHS Trust (Northwick Park Hospital)
state: Middlesex
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospitals NHS Foundation Trust
state: Norfolk
city: Carshalton
country: United Kingdom
facility: Epsom and St Helier's Hospitals NHS Trust
state: Surrey
city: Chichester
country: United Kingdom
facility: St Richard's Hospital
state: West Sussex
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)
state: West Yorkshire
city: Bath
country: United Kingdom
facility: Royal United Hospital NHS Trust
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospitals NHS Trust
city: Croydon
country: United Kingdom
facility: Croydon University Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Diana Tait
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Marsden Hospitals NHS Foundation Trust
name: Gina Brown
role: PRINCIPAL_INVESTIGATOR
References: