Can we save the rectum by watchful waiting or local surgery following (chemo)Radiotherapy versus radical surgery for early rectal Cancer?

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 120

Inclusion Criteria

• Biopsy proven adenocarcinoma of the rectum
• mriT1-3bN0 (with =5mm of mesorectal invasion) rectal tumour or endorectal ultrasound defined rectal cancer uT1-uT3b (optional: in centres where high quality ERUS is available and patient unable to tolerate MRI)
• MDT determines that all of the following treatment options are feasible: (a) TME surgery, (b) CRT (c) SCPRT d) TEM
• Patients with equivocal radiological lesions e.g. mesorectal, retroperitoneal, liver, lung are eligible if agreed by MDT
• Aged 16 or over in UK (18 or over in the Netherlands and Denmark).
Pre-treatment, the following criteria must be met:
• Estimated creatinine clearance >50 mls/min
• Absolute neutrophil count >1.5x109/l; platelets >100 x 109/L
• Serum transaminase <3 x Upper Limit Normal/l (ULN)
• Bilirubin <1.5 x ULN
• ECOG performance status 0-1
• If female and of childbearing potential, must:
o Have a negative pregnancy test =72hours prior to initiating study treatment
o Agree to avoid pregnancy during and for 6 months after study treatment
• If male with a partner of childbearing potential, must:
o Agree to use adequate, medically approved, contraceptive precautions during and for 90 days after the last dose of study treatment
• Patient able and willing to provide written informed consent for the study

Are the trial subjects under 18? yes
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Unequivocal evidence of metastatic disease (includes resectable metastases)
• MRI node positive (defined by protocol guidelines)
• MRI extramural vascular invasion (mriEMVI) positive (defined by protocol guidelines)
• MRI defined mucinous tumour
• Mesorectal fascia threatened (< 1 mm on MRI)
• Maximum tumour diameter > 40mm as measured from everted edges on sagittal MRI
• Tumour position anterior, above the peritoneal reflection on MRI or EUS
• No residual luminal tumour following endoscopic resection
• Contraindications to radiotherapy including previous pelvic radiotherapy
• Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months prior to randomisation)
• Known dihydropyrimidine dehydrogenase (DPYD) deficiency
• Known Gilberts disease (hyperbilirubinaemia)
• Taking warfarin that cannot be discontinued at least 7 days prior to starting treatment or substituted by low molecular weight heparin
• Taking phenytoin or sorivudine or its chemically related anologues, such as brivudine (see Section 8.4.5 for further details)
• As metronidazole interacts with capecitabine, patients who are taking Metronidazole, should be stopped at point of study entry (randomisation)
• Pregnant, lactating or pre-menopausal women not using adequate contraception.
• History of severe and unexpected reactions to fluoropyrimidine therapy
• Unable or unwilling to provide written informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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