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.

Rectal Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04103372
• Other study ID #: CCR 4993
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: April 2032

Study information

• Verified date: September 2019
• Source: Royal Marsden NHS Foundation Trust
• Contact: Gina Brown
• Phone: +442086613964
• Email: gina.brown[@]rmh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 146
• Est. completion date: April 2032
• Est. primary completion date: April 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Surveillance 6 monthly
6 monthly surveillance
• Radiotherapy and surveillance
as per local policy
• surveillance 3 montly
3 monthly surveillance

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHSHFT	Chelsea	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Pelican Cancer Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate a change in rectal preservation rates	Demonstrate a change in rectal preservation rates in patients with pT1 and pT2 tumours.	36 months
Secondary	To measure the accuracy of MRI T staging when compared with pathology.	To measure the accuracy of MRI T staging when compared with pathology.	36 months
Secondary	Rates of missed lesions for local excision	Report on rates of missed lesions suitable for local excision.	36 months
Secondary	Rates of lesions not for local excision	Report on rates of lesions not feasible for local excision	36 months
Secondary	Cost comparison	Compare costs to the NHS/other healthcare systems of major surgery versus local excision for pT1/T2 ERC.	36 months
Secondary	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.	36 months
Secondary	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.	36 months
Secondary	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).	36 months
Secondary	Assess patient willingness to be randomised	Assess patient willingness to be randomised by qualitative questionnaire	36 months