Inclusion & exclusion criteria

  1. 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)
  2. 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)
  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, deep mucosal infiltration (SM 3/Haggitt 4), and/or lymphatic and/or venous invasion, and / or tumor budding
  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. Age > 18 years
  9. Life expectancy of at least 12 months
  10. Medically fit (WHO 0-2) to undergo radical surgery and/or radiation
  11. The patient is willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations
  12. 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
  13. Written (signed and dated) informed consent and be capable of co-operating with protocol
  1. Incomplete resection (carcinoma in resection plane)
  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 cancer
  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
  11. History of severe and unexpected reactions to fluoropyrimidine therapy
  12. Hypersensitivity to capecitabine.
  13.  Patients with severe hepatic impairment.
  14. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
  15. Patients known with dihydropyrimidine dehydrogenase deficiency
  16. Any contra-indications to undergo MRI imaging
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