T1-3 N0 M0 distal rectal tumor (below 10 cm), based on diagnostic imaging MedDRA version: 12.1 Level: LLT Classification code 10038038 Term: Rectal cancer
Conditions
Interventions
Trade Name: Xeloda
Product Name: Capecitabine
Pharmaceutical Form: Coated tablet
Sponsors
University Medical Centre Nijmegen
Eligibility
Sex/Gender
All
Inclusion 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 tumor 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 formule) •Total serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found).;Secondary Objective: •Quality of Life Determine the faecal continence and QOL in all patients. •Local recurrence Careful follow-up will determine the local recurrence rate of patients treated with TEM or TME surgery ;Primary end point(s): The primary objective of the study is to determine the number of patients with minimal residual disease (ypT0-1) after neoadjuvant chemoradiation followed by TEM surgery. The resection specimen should be complete (> 2 mm margin) without evidence of nodal metastases (if nodes are found). | — |
Countries
Netherlands
Outcome results
None listed