Locally advanced rectal cancer
Conditions
Interventions
Trade Name: Xeloda
Product Name: Xeloda
Product Code: Ro 09-19784
Pharmaceutical Form: Film-coated tablet
Sponsors
Roche Slovensko s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histologically or cytologically confirmed diagnosis of rectal carcinoma, who are planned to have surgery for rectal cancer and are considered to have benefit from pre-operative combined chemo-radiotherapy, (stage cT3, cT4, fixative tumors, tumors primarily inoperaberable - Age more than 18 and less than 80 years – Outpatients, with ECOG performance status 0-2 – Patients willing and able to comply with the study protocol – Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Prior radiotherapy or chemotherapy for colorectal cancer. – Serious comorbidities: Congestive heart failure, angina pectoris, previous history of myocardial infarction, uncontrolled hypertension or arrhythmias. History of significant neurological or psychiatric disorders including dementia or seizures. Serious uncontrolled active infection. Other serious comorbidities that could affect patients safety during study – Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study screening. – Pregnant or lactating women. – Women of child-bearing potential unless using a reliable and appropriate contraceptive method (post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). – Sexually active males unwilling to practice contraception during the study. – Life expectancy of 1.5 x the upper-normal limits (UNL) of the Institutional normal values and ASAT,ALAT, GMT > 2.5 x UNL, alkaline phosphatase > 2.5 x UNL – Creatinine > 150 micromol/L or creatinine clearance < 30ml/min. – Significant stomach or small intestine disease. – Hypersensitivity to capecitabine, some of the excipients or flurouracil. – Known deficit of dihydropyrimidindehydrogenase (DPD). – Treatment with sorivudine or with chemically related analogues, e.g. brivudine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pathological complete response (pCR) rate in patients treated with capecitabine plus standard radiotherapy of the pelvic region followed by surgery;Secondary Objective: To assess the clinical tumor and lymph node response rate to chemo-radiotherapy. To evaluate the safety profile of capecitabine in combination with pelvic radiotherapy. ;Primary end point(s): Pathological confirmed complete response (pCR) rate, in patients treated with capecitabine plus ´standard technique´ radiotherapy of pelvic region. | — |
Countries
Slovakia
Outcome results
None listed