Patient has had a margin free (no carcinoma in resection plane) endoluminal local excision (by TEM, TAMIS, EMR/ESD or polypectomy) of an early rectal cancer (below 10 cm)
Only lesions for which total mesorectal excision (TME) surgery is indicated can be included (if a partial mesorectal excision (PME) is indicated the patient should be excluded)
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, deep mucosal infiltration (SM 3/Haggitt 4), and/or lymphatic and/or venous invasion, and / or tumor budding
Pathological confirmation of the rectal adenocarcinoma fulfilling the following criteria: pT2, maximum size 3 cm, well differentiated and without lymphatic or venous invasion.
Complete colonoscopy, without synchronous colorectal cancer
cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features
Adequate distant staging (CT-thorax/abdomen) without signs of distant metastasis (cM0)
Age > 18 years
Life expectancy of at least 12 months
Medically fit (WHO 0-2) to undergo radical surgery and/or radiation
The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations
No contraindications to chemotherapy, including adequate blood counts;
– white blood count >= 4.0 x 10 9/l
– platelet count >=100 x 109/l
– clinical acceptable haemoglobin levels
– bilirubin < 35 umol/l
– creatinine levels indicating renal clearance of >=50 ml/min
Written (signed and dated) informed consent and be capable of co-operating with protocol
Incomplete resection (carcinoma in resection plane)
T1 tumour < 3 cm, well differentiated, without venous or lymphatic invasion
T1 tumour >5 cm and T2 tumour > 3 cm
Presence of metastatic disease or recurrent rectal cancer
Previous pelvic radiation
Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment
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
Pregnancy, breast-feeding or fertile women without active birth control
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
Patients who are known to be serologically positive for Hepatitis B, Hepatitis C or HIV
History of severe and unexpected reactions to fluoropyrimidine therapy
Hypersensitivity to capecitabine.
Patients with severe hepatic impairment.
Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
Patients known with dihydropyrimidine dehydrogenase deficiency