Multicentre randomised phase II feasibility study evaluating neoadjuvant chemoradiotherapy plus surgery with Surgery Alone In LOw Rectal cancer

Morriston Hospital (UK)0 sites3 target enrollmentJune 6, 2013

Overview

Registry

who.int

Start Date

June 6, 2013

End Date

June 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Morriston Hospital (UK)

•Current inclusion criteria as of 24/02/2014:
•1\. Age 18 years and older
•2\. Histologically confirmed rectal adenocarcinoma
•3\. Radiologically measurable or clinically evaluable disease
•4\. Low rectal cancer, defined as within 6cm of anal verge on rigid sigmoidoscopy and considered to require abdominoperineal resection (APR) rather than restorative procedure (anterior resection)
•5\. Potentially resectable local disease by surgery alone with clear CRM (where visible on MRI) or predicted surgical resection margin (where CRM absent in distal tumours) as determined by MRI
•6\. Clinical disease stage (MRI\+/\- endorectal US):
•6\.1\. cT3a/b (\<10 mm) disease within 6 cm of anal verge; or for tumours at/below level of puborectalis
•6\.2\. through full thickness of muscularis propria (cT2\) disease at level of puborectalis
•7\. Involvement of internal anal sphincter or intersphincteric space without extension into adjacent levator plate,

•Current exclusion criteria as of 24/02/2014:
•1\. Preoperative chemoradiotherapy absolutely indicated, for example MRI\-predicted CRM/MRF involvement (\<1 mm) by primary or nodal disease, or otherwise unresectable disease;
•2\. cT3c or d (\>10 mm);
•3\. Adjacent organ involvement at entry (prostate, seminal vesicles, sacrum or coccyx; T4b) requiring multivisceral resection/ pelvic exenteration;
•4\. For low tumours at level of puborectalis sling: lateral extension of tumour into external anal sphincter or beyond puborectalis sling into levator plate;
•5\. Extramural vascular invasion on MRI;
•6\. Early stage rectal cancer (T1, T2 above level of levators) unless node positive;
•7\. Locally perforated disease (T4a);
•8\. Fistulating disease (vagina, perianal skin, adjacent hollow organ);
•9\. Disease extrusion through anus;