Rectal cancer stage II and III
Conditions
Interventions
Trade Name: XELODA
Product Name: XELODA
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CAPECITABINE
CAS Number: 154361-50-9
Concentration unit: mg milligram(s)
Concentration type: equal
Conce
Sponsors
DSC Services, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Newly diagnosed, histologically verified rectal adenocarcinoma, clinical stage II or III (cT3 - 4 N0 M0, or any of cT N1 - 2 M0), localized up to 16cm from anus. Karnofsky index > 70. Age 18-70yrs Complete Blood Count (+differential count): WBC, trombocytes, neutrophils in peripheral blood with no clinical pathology, haemoglobin level at least 100mg/l Hepatic enzymes serum level (ALT,AST,LD,GMT and bilirubin) up to twice as the upper limit of the normal range Serum creatine level less than 140 mmol.l-1, creatine clearance > 60 ml/min. In case of border level of creatinine clearance (45 – 60 ml/min) test may be repeated or specified by kidney scintigraphy (DTPA) and inclusion may be consulted with clinical coordinator. Signed 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: Serious complications demanding acute or subacute treatment (ileus, GIT perforation or clinically important bleeding) Suspicion on synchronic duplicit malignant tumors in the region of rectum or colon, multiple polyposis in the region of rectum or colon Active infectious disease Other malignant tumor disease in the past 5 years excluding basalioma and cervical cancer (carcinoma in situ). Previous radiotherapy of a small pelvis or other treatment of abdomen or small pelvis having large effect on normal anatomy Serious cardiovascular disease Serious mental disease, active or present in patient history Fluoropyrimidine related serious unexpected reaction Capecitabine(Xeloda®), 5-fluorouracil or any of present substances hypersensitivity Autoimmune disease, active or in patient history Known DPD (dihydropryimidine dehydrogenasis) deficiency Enormous vomiting or any other state excluding oral administration Sirovudine concomitant administration of of its chemical analog Peroral anticoagulans administration (warfarin) Gravidity or breastfeeding Presence of any mental, familiar, social or geographic facts that may be collide with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary end point: to set and to compare the portion of complete histopathological remissions between two arms A and B defined by histopathological examination of the surgical sample. ;Secondary Objective: Secondary end points: to set and to compare between arms A and B: downstaging frequency reached by neoadjuvant treatment Portion of anal sphincter sparing surgeries Frequency of local recurrences during 2 and 5 year follow up Disease-free interval Overall survival Frequency and seriousness of adverse events Quality of life;Primary end point(s): Primary end point: to set and to compare the portion of complete histopathological remissions between two arms A and B defined by histopathological examination of the surgical sample. | — |
Countries
Czech Republic
Outcome results
None listed