Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01273051
Eligibility Criteria:
Inclusion Criteria:
* 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).
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 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 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01273051
Study Brief:
Protocol Section:
NCT01273051