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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: 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 ]

Original Primary Outcome: The proportion of patients downstaged by T stage will be expressed as a percentage with 95% confidence interval (95% CI) for each treatment arm and compared between the two arms using the Fisher's exact test. [ Time Frame: 6-12 weeks ]

Current Secondary Outcome:

  • Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI]. [ Time Frame: 3 months ]
  • Difference in proportion of patients in each arm undergoing sphincter saving surgery. [ Time Frame: 3 months ]
  • Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity. [ Time Frame: 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. [ Time Frame: 3 months ]
  • Local and distant recurrence rates. [ Time Frame: 5 years ]
  • Radiotherapy related toxicity rates. [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Patients showing reduction in a) T stage, b) N stage and c) Tumour regression. [ Time Frame: 3 months ]
  • Patients having sphincter sparing surgery compared by Fisher's exact test. [ Time Frame: 3 months ]
  • Morbidity, 30 day mortality and CRM positivity will be compared using Fisher's exact test or the Chi squared test. [ Time Frame: 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. [ Time Frame: 3 months ]


Information By: Royal Marsden NHS Foundation Trust

Dates:
Date Received: December 18, 2009
Date Started: October 2009
Date Completion: July 2019
Last Updated: June 22, 2015
Last Verified: November 2013