Clinical Trial: Assessing Outcomes in Primary or Recurrent Rectal or Sigmoid Cancer With Tumour Extending Beyond the TME Plane (Beyond TME)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessing Outcomes in Primary or Recurrent Rectal or Sigmoid Cancer With Tumour Extending Beyond the TME Plane

Brief Summary:

In the UK approximately 28,000 patients per year are diagnosed with bowel cancer. Further 15-20% develop pelvic recurrence. In a significant proportion of patients (15-20%), tumour extends beyond what the surgeon can routinely remove and requires more extensive (exenterative) surgery to achieve successful removal of the tumour. Currently MRI is used for the assessment of the pelvic tumour and PET/CT is used in order to prove that there is no extrapelvic disease, for the selection of patients who will undergo such a complex surgery. The investigators have previously shown, with a single centre retrospective analysis, that using a specific staging system for these tumours it is possible to predict both the likelihood of surgical success and overall survival outcomes. Until today there are no national guidelines for this group of patients.

The investigators want to test whether standardizing the assessment of these advanced tumours will help to improve outcomes for patients and better surgical planning. The investigators also want to show that the information from the scans gives valuable data regarding the long term outcomes and likelihood of surgical success.

This is a multicentre prospective trial of patients, who require more extensive surgery, using the staging classification. The high resolution MRI scans that patients undergo before surgery will be reported using the previously validated system.

It is hoped that the study will result in a better and standarised method of assessing advanced pelvic cancer, with the intent to improve the surgical planning and overall patient management, which may increase the possibility of surgical curative resection.


Detailed Summary:

Currently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis, this will enable clear selection criteria to be established and will improve surgical planning. This will result in an overall improvement in curative surgery which is currently only 67% at best in global series. Furthermore, overall 3 year cancer specific survival for patients undergoing this form of surgery without detailed MRI planning is only 35%. Incorrect preoperative staging and planning can result in patients undergoing unnecessary surgery (up to 40%) or being refused a potentially curative operation in 17% of the cases.

The design of the study is to be able to show that we have diagnostic accuracy with the use of the proposed staging system. The staging system will be validated against survival outcomes, also taking account of surgical morbidity outcomes and Quality Of Life measures.

The primary endpoint is to demonstrate a histopathological complete resection with clear margin rate (R0) of >greater than 67% (that is documented in the current literature) can be achieved using MRI compartmental classification planned exenterative surgery.


Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: Percentage of patients with R0 resection [ Time Frame: 3 years ]

Original Primary Outcome: Percentage of patients with R0 resection [ Time Frame: 5 years ]

Current Secondary Outcome:

  • Overall Survival and disease-free survival. [ Time Frame: 3 years ]
  • Percentage of scans showing disease by pelvic compartment [ Time Frame: 3 years ]
  • Inter-observer radiological agreement for each compartment. [ Time Frame: 3 years ]
  • SUV values in each pelvic compartment [ Time Frame: 3 years ]
  • Restriction in DWI in the seven (7) different pelvic compartments. [ Time Frame: 3 years ]
  • Proportion of patients with mutated KRAS and BRAF oncogenes [ Time Frame: 3 years ]
  • QLQ-C30 scores at baseline, 1 and 3 years. Occurrence of 30 Day Morbidity and Mortality [ Time Frame: 3 years ]


Original Secondary Outcome:

  • Overall Survival and disease-free survival. [ Time Frame: 5 years ]
  • Percentage of scans showing disease by pelvic compartment [ Time Frame: 5 years ]
  • Inter-observer radiological agreement for each compartment. [ Time Frame: 5 years ]
  • SUV values in each pelvic compartment [ Time Frame: 5 years ]
  • Restriction in DWI in the seven (7) different pelvic compartments. [ Time Frame: 5 years ]
  • Proportion of patients with mutated KRAS and BRAF oncogenes [ Time Frame: 5 years ]
  • QLQ-C30 scores at baseline, 1 and 3 years. Occurrence of 30 Day Morbidity and Mortality [ Time Frame: 5 years ]


Information By: Royal Marsden NHS Foundation Trust

Dates:
Date Received: May 2, 2014
Date Started: October 2014
Date Completion: October 2019
Last Updated: March 8, 2017
Last Verified: March 2017