CHEMORADIOTHERAPY FOR RECTAL CANCER IN THE DISTAL RECTUM FOLLOWED BY ORGANSPARING TRANSANAL ENDOSCOPIC MICROSURGERY: CARTS Study CApecitabine, Radiotherapy and Tem Surgery. A PHASE II, FEASIBILITY TRIAL
- Patients (aged >18 years) with histological proven adenocarcinoma of the distal part
of the rectum (below 10 cm) without signs of distant metastases.
- T1-3 tumour without lymph nodes > 5 mm at CT, MRI and endoanal ultrasound.
- ANC > 1.5 x 109/l.
- Thrombocytes > 100 x 109/l.
- Creatinin clearance >50ml/min (according to the Cockcroft-Gault formula)
- Total serum bilirubin < 24 mol/l or below <1.5 times the upper limit of the normal.
- ASAT,ALAT: up to 5 times the upper limit.
- Colonoscopy, colonography or virtual colonoscopy should exclude synchronous
colorectal lesions in other parts of the colon.
- ECOG performance score 0-2.
- Fertile women should have adequate birth control during treatment.
- Mental/physical/geographical ability to undergo treatment and follow-up.
- Written informed consent (Dutch language).
- Patients with Grade 1-2 T1 tumors (can be treated with TEM surgery without
- Patients with circular rectal tumor or tumors who are by other means unacceptable for
TEM surgery (e.g. intra anal tumors).
- Patients with faecal incontinence prior to the diagnosis of rectal cancer (complaints
of soiling due to the tumor will not be an exclusion criterium).
- Severe uncontrollable medical or neurological disease.
- Patients with secondary prognosis determining malignancies.
- Patients who have been treated with radiotherapy on the pelvis.
- Use of Vitamin K antagonists.
- Fenytoine and Allopurinol use.
- Known DPD deficiency
- Uncontrolled active infection, compromised immune status, psychosis, or CNS disease.
- Pregnant or lactating women.
- Clinically significant (i.e. active) cardiovascular disease for example
cerebrovascular accidents (≤ 6 months prior to randomisation), myocardial infarction
(≤ 6 months prior to randomisation), unstable angina, New York Heart Association
(NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia
- Evidence of other disease, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates use of Capecitabine or patients at high risk for treatment
complications. History or evidence upon physical examination of CNS disease unless
adequately treated (e.g., seizure not controlled with standard medical therapy).