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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01037049
First received: December 18, 2009
Last updated: June 22, 2015
Last verified: November 2013
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

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]. [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference in proportion of patients in each arm undergoing sphincter saving surgery. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Local and distant recurrence rates. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Radiotherapy related toxicity rates. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 237
Study Start Date: October 2009
Estimated Study Completion Date: July 2019
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037049

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

Additional Information:
No publications provided

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01037049     History of Changes
Other Study ID Numbers: CCR3227
Study First Received: December 18, 2009
Last Updated: June 22, 2015
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
Rectal Cancer
6vs12
6 vs 12
Cancer
CRM
Circumferential Resection Margin
Quality of Life
MRI
Radiology
Abdominoperineal Excision
Anterior Resection
Surgery
Pathology
Radiotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Mucinous
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases
Rectal Neoplasms
Carcinoma
Colonic Diseases
Neoplasms, Cystic, Mucinous, and Serous

ClinicalTrials.gov processed this record on July 28, 2015