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

NCT01037049 | Unknown Phase 2 DMC

• 1 other identifier: CCR3227
• Study Type: interventional
• Target: 237
• Locations: 4 countries
• Sites: 23

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Group 1

NO INTERVENTION

Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy

Group 2

EXPERIMENTAL

Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy

Interventions

Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy OTHER

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \> 18
• Informed written consent
• Histological confirmation of adenocarcinoma of rectum
• Undergoing pre-operative radiotherapy/ chemotherapy
• Completion of pre-operative treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (23)

Hospital Alemão Oswaldo Cruz

São Paulo, 01323-903, Brazil

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Bank of Cyprus Oncology Centre

Nicosia, Cyprus

Location

Hinchingbrooke Hospital

Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom

Location

County Durham and Darlington NHS Trust (University Hospital of North Durham)

Durham, County Durham, DH1 5TW, United Kingdom

Location

North Tees and Hartlepool NHS Trust (University Hospital of North Tees)

Stockton-on-Tees, County Durham, TS24 9AH, United Kingdom

Location

Dorset County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

Poole Hospital NHS Foundation Trust

Poole, Dorset, BH15 2JB, United Kingdom

Location

Essex County Hospital

Colchester, Essex, CO3 3NB, United Kingdom

Location

Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

Location

North West London Hospitals NHS Trust (Northwick Park Hospital)

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

James Paget University Hospitals NHS Foundation Trust

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

Location

Epsom and St Helier's Hospitals NHS Trust

Carshalton, Surrey, SM5 1AA, United Kingdom

Location

St Richard's Hospital

Chichester, West Sussex, PO19 6SE, United Kingdom

Location

Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

Location

Royal United Hospital NHS Trust

Bath, BA1 3NG, United Kingdom

Location

Sandwell and West Birmingham Hospitals NHS Trust

Birmingham, B18 7QH, United Kingdom

Location

Croydon University Hospital

Croydon, CR7 7YE, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

St George's Healthcare NHS Trust

London, SW17 0QT, United Kingdom

Location

Pennine Acute Hospitals NHS Trust

Manchester, M8 5RB, United Kingdom

Location

Royal Marsden NHS Trust

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms; 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

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Colonic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Diana Tait

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Gina Brown

  Royal Marsden Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2009
• First Posted: December 21, 2009
• Study Start: October 16, 2009
• Primary Completion: December 8, 2014
• Study Completion: December 8, 2019
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

BR (1); CA (1); CY (1); GB (20)