A feasibility trial to evaluate the use of an an imaging biomarker called magnetic resonance tumour regression grade (mrTRG) to identify and manage good and poor responders to chemoradiotherapy for use in patients with rectal (bowel) cancer.

Conditions: Rectal cancer
MedDRA version: 18.0Level: PTClassification code 10061758Term: ChemotherapySystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 18.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003009-40-GB

Lead Sponsor: Royal Marsden NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1) Have metastatic disease (including resectable liver metastases)
2) Are contraindicated for MRI eg. non-mr compatable 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) or systemic chemotherapy
5) Are receiving or planned to receive treatment outside of that stipulated by the protocol,such as an alternative cytotoxic or investigational drug.
6) Are pregnant, breastfeeding or unable / unwilling to comply with pregnancy prevention guidelines
7) 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