Clinical Trial: Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

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

Official Title: Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Brief Summary:

The IMPRESS trial aims to see whether the improved results can be achieved for patients with pelvic sigmoid cancers by having an MRI scan prior to surgery so that doctors can make the most appropriate treatment choice.

Everyone who agrees to take part will be randomly allocated by one of the research team to either have standard treatment for sigmoid cancer, which involves CT-imaging of chest and abdomen / pelvis before surgery, or to undergo standard treatment, plus an additional MRI scan, before surgery. The additional MRI scan will be the only difference in approach between the two arms of the trial. After all imaging is obtained, patients from both arms will be discussed by the Multidisciplinary Team as usual. An amendment to this study in 2015 allowed for patients with sigmoid cancer who receive an MRI by local indication to be entered into the trial as observational patients, and a new primary endpoint added that compares the rates of high risk features identified between CT and MRI scans for all patients.


Detailed Summary:

The primary objective of the IMPRESS Trial will be to compare the proportion of patients undergoing any radical treatment in the two arms of the study. Another primary endpoint is to measure the difference in detection of high risk patients when comparing CT and MRI for all patients.

Secondary outcomes will measure the proportion of patients who underwent neoadjuvant treatment, quality of surgery including free resection margins, perioperative morbidity and mortality, permanent defunctioning stoma rates, downstaging, quality of life at 1 year, 3 years and 5 years.


Sponsor: Royal Marsden NHS Foundation Trust

Current Primary Outcome: To measure the difference in treatment stratification policy caused by the difference in findings between the CT and MRI. [ Time Frame: 1 year post-surgery ]

Treatment is defined as (pre-operative) neoadjuvant treatment and/or extended surgery which would be offered for CT or MRI detected advanced T3 (>T3b), EMVI positive, CRM involved sigmoid cancers. This objective will be assessed in both the observational and randomisation pathways.

Patients shown to have irresectable disease at baseline will be excluded from the primary endpoint analysis. Patients will be eligible for inclusion in the primary endpoint only if they have completed their planned baseline imaging (CT or CT+MRI) and were intended for curative treatment based on imaging results. Patients who subsequently withdrew from the trial for any reason before completion of curative treatment will be included in the analysis.



Original Primary Outcome: To compare the proportion of patients undergoing any radical treatment in the two arms of the study [ Time Frame: 5 years after last recruit ]

Radical treatment is defined as no evidence of tumour residue after treatment including surgery and (neo)adjuvant treatment.

Patients shown to have irresectable disease at baseline will be excluded from the primary endpoint analysis. Patients will be eligible for inclusion in the primary endpoint only if they have completed their planned baseline imaging (CT or CT+MRI) and were intended for curative treatment based on imaging results. Patients who subsequently withdrew from the trial for any reason before completion of curative treatment will be included in the analysis.



Current Secondary Outcome:

  • To measure the proportion of patients who underwent neoadjuvant treatment in each arm. [ Time Frame: 5 years after last recruit ]
  • To compare the quality of surgery, including free resection margins, in each arm. [ Time Frame: 5 years after last recruit ]
    Quality of surgery will be assessed by the pathologist using a proforma sheet. Surgical resection margins, the amount of mesentery taken out and any peritoneal tears and length of vascular tie will be recorded.
  • To compare the perioperative morbidity and mortality in each arm. [ Time Frame: 5 years after last recruit ]
    Perioperative morbidity will include all adverse events within 30 days postoperatively. Perioperative mortality will include all deaths irrespective of cause within 30 days postoperatively.
  • To measure and compare permanent defunctioning stoma rates in each arm. [ Time Frame: 5 years after last recruit ]
    Permanent defunctioning stomas is defined as stomas not reversed within 5 years postoperative follow-up.
  • To measure and compare radiological downstaging in each arm. [ Time Frame: 5 years after last recruit. ]
    Downstaging is defined as any improving of radiological TNM-stage on MRI after neoadjuvant treatment.
  • To compare quality of life at 1 year, 3 years and 5 years in each arm. [ Time Frame: 5 years after last recruit. ]
    Using EORTC QLQ - CR29 quality of life form.
  • To compare the proportion of patients having radical treatment between arms in the randomisation pathway [ Time Frame: 5 years after last patient recruited ]


Original Secondary Outcome:

  • To measure the proportion of patients who underwent neoadjuvant treatment in each arm. [ Time Frame: 5 years after last recruit ]
  • To compare the quality of surgery, including free resection margins, in each arm. [ Time Frame: 5 years after last recruit ]
    Quality of surgery will be assessed by the pathologist using a proforma sheet. Surgical resection margins, the amount of mesentery taken out and any peritoneal tears and length of vascular tie will be recorded.
  • To compare the perioperative morbidity and mortality in each arm. [ Time Frame: 5 years after last recruit ]
    Perioperative morbidity will include all adverse events within 30 days postoperatively. Perioperative mortality will include all deaths irrespective of cause within 30 days postoperatively.
  • To measure and compare permanent defunctioning stoma rates in each arm. [ Time Frame: 5 years after last recruit ]
    Permanent defunctioning stomas is defined as stomas not reversed within 5 years postoperative follow-up.
  • To measure and compare radiological downstaging in each arm. [ Time Frame: 5 years after last recruit. ]
    Downstaging is defined as any improving of radiological TNM-stage on MRI after neoadjuvant treatment.
  • To compare quality of life at 1 year, 3 years and 5 years in each arm. [ Time Frame: 5 years after last recruit. ]
    Using EORTC QLQ - CR29 quality of life form.


Information By: Royal Marsden NHS Foundation Trust

Dates:
Date Received: August 20, 2014
Date Started: August 2014
Date Completion: January 2021
Last Updated: March 17, 2017
Last Verified: March 2017