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Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer. (PRESERVE)

Primary Purpose

Rectal Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Surveillance 6 monthly
Radiotherapy and surveillance
surveillance 3 montly
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring early stage, early phase

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • mrT3b tumour or less on initial assessment
  • Absence of mrEMVI / mrN1c deposits
  • mrCRM clear >1mm
  • Rectal lesion as defined on MRI/Endoscopy. (If patients are registered at endoscopy and later found, on MRI, not to have a rectal ERC, they should be withdrawn from the study)
  • Over 18 years of age
  • Of adequate performance status to be able to undergo surgery if necessary

Exclusion Criteria:

  • are requiring neoadjuvant therapy for MRI-staged advanced rectal cancer
  • have metastatic disease
  • have a second malignancy where there is <95% certainty of survival from the treated disease
  • are unable to consent or withhold consent
  • have biopsy-proven malignancy which is not adenocarcinoma (Patients do not need to have had a biopsy prior to registration. However, if after excision the ERC is found to either not be an adenocarcinoma or be benign, the patient should be withdrawn from the study.)

Sites / Locations

  • The Royal Marsden NHSHFT

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Low risk

Moderate Risk - RT&Surveillance

Moderate Risk - Surveillance

High Risk

TME (Total mesorectal excision) Surgery

Arm Description

MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 0. (Margin Clear >0mm from the diathermy margin and Sm1/2 or Haggitt 1/2/3) Six monthly follow up from date of surgery.

MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to receive radiotherapy (RT) and regular surveillance, with 3 monthly follow-up from the date of surgery.

MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to surveillance arm with regular surveillance, with 3 monthly follow-up from the date of surgery.

MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of >2. (Margin positive - 0mm to the diathermy margin, Margin positive/or unassessable due to piecemeal removal - 0mm to the tumour margin, Sm3 or Haggitt 4, Poorly differentiated/mucinous, LVI, T2) Patient is considered for surgery, receives radiotherapy and surveillance, with 3 monthly follow-up from date of surgery.

For patients where it is considered technically feasible to do LE but MR staged<1mm muscularis preserved, or it is considered not feasible to perform a local excision. Patients undergo TME surgery. Pathology assessment on sample with confirmation of adenocarcinoma. Patient receives 6 monthly follow-up from date of surgery.

Outcomes

Primary Outcome Measures

Demonstrate a change in rectal preservation rates
Demonstrate a change in rectal preservation rates in patients with pT1 and pT2 tumours.

Secondary Outcome Measures

To measure the accuracy of MRI T staging when compared with pathology.
To measure the accuracy of MRI T staging when compared with pathology.
Rates of missed lesions for local excision
Report on rates of missed lesions suitable for local excision.
Rates of lesions not for local excision
Report on rates of lesions not feasible for local excision
Cost comparison
Compare costs to the NHS/other healthcare systems of major surgery versus local excision for pT1/T2 ERC.
Measure impact on patient quality of life
Measure impacts of local excision and rectal preservation on patient reported quality of life outcome measures compared with stage matched patients undergoing major surgery due to patient choice or technical inability to undertake locale scission. Measurement tools used for assessment are the LARS (low anterior resection syndrome) score, the EQ-5D and Stoma Care Quality of Life Questionnaire.
Measure relapse-free rates at 1 year post surgery / local excision.
Put in a separate point saying: Measure survival rates at 1 year post surgery / local excision.
Assess the quality of local excision surgery
To assess the quality of local excision surgery, using review of pathology slides and reports, commenting on completeness of excision, excision margins and en bloc manner of resection (local excision specimens).
Assess patient willingness to be randomised
Assess patient willingness to be randomised by qualitative questionnaire

Full Information

First Posted
September 5, 2019
Last Updated
September 23, 2019
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Pelican Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04103372
Brief Title
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.
Acronym
PRESERVE
Official Title
Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
April 2032 (Anticipated)
Study Completion Date
April 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Pelican Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This multicentre, prospective, randomised, feasibility trial aims to change UK practice by enabling more patients with early rectal cancer to safely undergo local excision rather than major surgery thus maintaining quality of life without compromising survival outcomes.
Detailed Description
The national bowel cancer screening programme (BCSP) has shown an increase in detection rates of early rectal cancer (ERC). This is treated effectively with radical surgery, offering excellent oncological outcome, but has a major impact on patient quality of life. The diagnosis of early stage rectal cancer, allows an opportunity for effective oncological treatment, with preservation of the rectum avoiding the deleterious effects of unselective use of radical surgery and unselected use of radiotherapy. Our previous work has led to High-Spatial-Resolution magnetic resonance imaging (MRI) as the established modality for providing reliable information about extramural disease prior to radical surgery. This trial will use a new MRI staging protocol to identify more patients with early rectal cancer to enable accurate mapping for more precise patient selection for local excision. Improved success with local excision will result in greater rates of organ preservation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
early stage, early phase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low risk
Arm Type
Active Comparator
Arm Description
MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 0. (Margin Clear >0mm from the diathermy margin and Sm1/2 or Haggitt 1/2/3) Six monthly follow up from date of surgery.
Arm Title
Moderate Risk - RT&Surveillance
Arm Type
Active Comparator
Arm Description
MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to receive radiotherapy (RT) and regular surveillance, with 3 monthly follow-up from the date of surgery.
Arm Title
Moderate Risk - Surveillance
Arm Type
Active Comparator
Arm Description
MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of 1. (Margin positive -0mm to the diathermy margin, or SM3 or Haggitt 4, or LVI) Patient randomized to surveillance arm with regular surveillance, with 3 monthly follow-up from the date of surgery.
Arm Title
High Risk
Arm Type
Active Comparator
Arm Description
MR Staged >1mm muscularis preserved and technically feasible to perform local excision. Pathology assessment on sample with confirmation of adenocarcinoma. Sample assessed to be low risk based on PRESERVE Risk Score of >2. (Margin positive - 0mm to the diathermy margin, Margin positive/or unassessable due to piecemeal removal - 0mm to the tumour margin, Sm3 or Haggitt 4, Poorly differentiated/mucinous, LVI, T2) Patient is considered for surgery, receives radiotherapy and surveillance, with 3 monthly follow-up from date of surgery.
Arm Title
TME (Total mesorectal excision) Surgery
Arm Type
Active Comparator
Arm Description
For patients where it is considered technically feasible to do LE but MR staged<1mm muscularis preserved, or it is considered not feasible to perform a local excision. Patients undergo TME surgery. Pathology assessment on sample with confirmation of adenocarcinoma. Patient receives 6 monthly follow-up from date of surgery.
Intervention Type
Other
Intervention Name(s)
Surveillance 6 monthly
Intervention Description
6 monthly surveillance
Intervention Type
Other
Intervention Name(s)
Radiotherapy and surveillance
Intervention Description
as per local policy
Intervention Type
Other
Intervention Name(s)
surveillance 3 montly
Intervention Description
3 monthly surveillance
Primary Outcome Measure Information:
Title
Demonstrate a change in rectal preservation rates
Description
Demonstrate a change in rectal preservation rates in patients with pT1 and pT2 tumours.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
To measure the accuracy of MRI T staging when compared with pathology.
Description
To measure the accuracy of MRI T staging when compared with pathology.
Time Frame
36 months
Title
Rates of missed lesions for local excision
Description
Report on rates of missed lesions suitable for local excision.
Time Frame
36 months
Title
Rates of lesions not for local excision
Description
Report on rates of lesions not feasible for local excision
Time Frame
36 months
Title
Cost comparison
Description
Compare costs to the NHS/other healthcare systems of major surgery versus local excision for pT1/T2 ERC.
Time Frame
36 months
Title
Measure impact on patient quality of life
Description
Measure impacts of local excision and rectal preservation on patient reported quality of life outcome measures compared with stage matched patients undergoing major surgery due to patient choice or technical inability to undertake locale scission. Measurement tools used for assessment are the LARS (low anterior resection syndrome) score, the EQ-5D and Stoma Care Quality of Life Questionnaire.
Time Frame
36 months
Title
Measure relapse-free rates at 1 year post surgery / local excision.
Description
Put in a separate point saying: Measure survival rates at 1 year post surgery / local excision.
Time Frame
36 months
Title
Assess the quality of local excision surgery
Description
To assess the quality of local excision surgery, using review of pathology slides and reports, commenting on completeness of excision, excision margins and en bloc manner of resection (local excision specimens).
Time Frame
36 months
Title
Assess patient willingness to be randomised
Description
Assess patient willingness to be randomised by qualitative questionnaire
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: mrT3b tumour or less on initial assessment Absence of mrEMVI / mrN1c deposits mrCRM clear >1mm Rectal lesion as defined on MRI/Endoscopy. (If patients are registered at endoscopy and later found, on MRI, not to have a rectal ERC, they should be withdrawn from the study) Over 18 years of age Of adequate performance status to be able to undergo surgery if necessary Exclusion Criteria: are requiring neoadjuvant therapy for MRI-staged advanced rectal cancer have metastatic disease have a second malignancy where there is <95% certainty of survival from the treated disease are unable to consent or withhold consent have biopsy-proven malignancy which is not adenocarcinoma (Patients do not need to have had a biopsy prior to registration. However, if after excision the ERC is found to either not be an adenocarcinoma or be benign, the patient should be withdrawn from the study.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gina Brown
Phone
+442086613964
Email
gina.brown@rmh.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Xian van Gelder
Phone
+442086426011
Ext
4344
Email
xian.vangelder@rmh.nhs.uk
Facility Information:
Facility Name
The Royal Marsden NHSHFT
City
Chelsea
State/Province
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Brown
Phone
+442086613964
Email
gina.brown@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Xian van Gelder
Phone
+442086426011
Ext
4344
Email
xian.vangelder@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Gina Brown

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pre-therapeutic MRI Assessment of Early Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery: A New Approach to the Management of Early Stage Rectal Cancer.

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