Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers. - TESAR

Vrije Universiteit Medical Center0 sitesJuly 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Vrije Universiteit Medical Center

•1\.Patient has had a margin free (at least 1 mm) endoluminal local excision (by TEM, TAMIS, TSPM, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm).
•2\. Only lesions for which TME surgery is indicated can be included (If a partial mesorectal excision (PME) is indicated the patient should be excluded).
•3\.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: T1 with size 3\-5 cm or pT1, maximum size 3 cm, with at least poor differentiation and/or lymphatic and/or venous invasion
•4\.Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size 3 cm, well differentiated and without lymphatic or venous invasion.
•5\.Complete colonoscopy, without synchronous colorectal cancer
•6\.cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features .
•7\.Adequate distant staging (CT\-thorax abdomen) without signs of distant metastasis (cM0\)
•8\.Male or female, Age \> 18 years.
•9\.Life expectancy of at least 12 months.
•10\.Medically fit (WHO 0\-2\) to undergo radical surgery and/or radiation

•1\.Incomplete or inconclusive resection margin (less than 1mm clearance from the local excision margin or specimens with uncertain deep margin).
•2\.T1 tumour \< 3 cm, well differentiated, without venous or lymphatic invasion.
•3\.T1 tumour \>5 cm and T2 tumour \> 3 cm
•4\. Presence of metastatic disease or recurrent rectal tumour.
•5\.Previous pelvic radiation
•6\.Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment.
•7\.Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease\-free for at least 5 years.
•8\. Pregnancy, breast\-feeding or fertile women without active birth control
•9\.Clinically significant (i.e. active) cardiovascular disease for example cerebro vascular accidents (\<6 months prior to randomization), myocardial infarction (\<6 months prior to randomization), unstable angina, New York Heart Association (NYHA) grade II or higher, congestive heart failure, serious cardiac arrhythmia requiring medication.
•10\. Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV.