Magnetic Resonance Tumour Regression Grade as Biomarker for Stratified Management of Rectal Cancer Patients

Phase 2

Conditions: Rectal carcinoma

Registration Number: SLCTR/2017/012

Lead Sponsor: Faculty of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Male and female patients aged 18 years and older
2. Have a biopsy-confirmed adenocarcinoma 0-15cm from the anal verge (on MRI or rigid sigmoidoscopy).
3. Have locally Advanced Rectal Carcinoma diagnosed by MRI (mrCRM unsafe or >mrT3c [>5mm beyond muscularis propria] or mrEMVI positive disease)
4. Be deemed to require chemoradiotherapy.
5. Scheduled to receive 45Gy - 55Gy long course radiotherapy.
6. Have provided written informed consent to participate in the study.

Exclusion Criteria

1. Have metastatic disease (including resectable liver metastases).
2. Are contraindicated for MRI e.g. non-MR compatible hip prosthesis, cardiac pacemaker.
3. Are scheduled to receive less than 45Gy or more than 55Gy long course radiotherapy.
4. Are contraindicated for chemoradiotherapy (CRT)
5. Hypersensitivity or contraindication to the drug(s) associated with the planned choice of systemic chemotherapy (CAPOX, FOLFOX or single agent 5-FU or capecitabine) as stated in the SmPC for each of the drugs.
6. Are receiving or planned to receive treatment outside of that stipulated by the protocol, such as an alternative cytotoxic or investigational drug.
7. Are pregnant, breastfeeding or unable / unwilling to comply with pregnancy prevention guidelines.
8. Any other malignant disease within the preceding 5 years with the exception of non- melanomatous skin cancer, carcinoma in situ and early stage disease with <5% recurrence risk

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient recruitment rate<br>Total number of patients randomised per month during the last 4 months from completion of recruitment [Last 4 months until completion of recruitment ]<br>

Secondary Outcome Measures

Name	Time	Method
Pathology circumferential resection margin (pCRM) involvement rate<br>Overall pCRM involvement rate between the control and intervention arm [ pCRM involvement rate: <br><br>Control arm: at 12 weeks. <br><br>Intervention arm - poor response subgroup: 6 months. <br><br>Intervention arm - good response subgroup: a median of 2 years. ]<br>Drug toxicity. Toxicity will be graded using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grade 3-5 adverse events will be compared between the control and intervention arms. [Up to 1 year]<br>Surgical morbidity reported according to Clavien-Dindo classification [At 30 days and 12 months ]<br>Quality of surgery determined using the mesorectal grading system. [At time of surgery ]<br>Strength of agreement of reported mrTRG between site and central radiologists.<br>Agreement (kappa) between site and central radiologists for reported mrTRG for MRI scans performed at baseline, post-CRT and during surveillance schedule. [At baseline and 5 years. <br>]<br>