CHEMORADIOTHERAPY FOR RECTAL CANCER IN THE DISTAL RECTUM FOLLOWED BY ORGAN-SPARING TRANSANAL ENDOSCOPIC MICROSURGERY CARTS study CApecitabine, Radiotherapy and Tem Surgery. A PHASE II, FEASIBILITY TRIA

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 55

Inclusion Criteria

•Patients (aged >18 years) with histological proven adenocarcinoma of the distal third of the rectum without signs of distant metastases.
•T1-3 tumor without lymph nodes > 5 mm at CT, MRI and endoanal ultrasound.
•ANC > 1.5 x 10g/l.
•Thrombocytes > 100 x 109/l.
•Creatinin clearance >50ml/min (according to the Cockcroft-Gault formule)
•Total serum bilirubin < 24 mmol/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 birthcontrol during treatment.
•Mental/physical/geographical ability to undergo treatment and follow-up.
•Written informed consent (Dutch language).

Exclusion Criteria

•Patients with Grade 1-2 T1 tumors (can be treated with TEM surgery without chemoradiation therapy)
•Patients with circular rectal tumor or tumors who are by other means unacceptable for TEM surgery (e.g. intra-analtumors).
•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 Warfarin.
•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 requiring medication.
• 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the response of the rectal carcinoma to chemo-/radiotherapy<br /><br>defined as complete response (no visible disease); partial response (more than<br /><br>50% reduction of the tumour mass); no response (meaning an increase of the<br /><br>tumour mass less than 25% or a decrease of the tumour mass less than 50%); or<br /><br>progressive disease when the tumour mass increase more than 25% of the original<br /><br>tumour mass. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Quality of life. Occurrence of local recurrence. Toxicity. Number of positive<br /><br>lymphnodes in patients who have been treated with classical surgery. The number<br /><br>of sphincter saving procedures after organ sparing surgery by TEM or after<br /><br>classical TME surgery. </p><br>