Status: Recruiting

Official Title: An open label study to evaluate the safety of Xeloda as adjuvant monotherapy in patients who have undergone surgery for colon cancer, Dukes stage C.

Brief Summary: This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Study Phase: 4

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Colorectal Cancer

Intervention Type: Drug

Intervention Name: capecitabine [Xeloda]

• adult patients, >=18 years of age;
• colon cancer (Dukes stage C);
• surgery, with no evidence of remaining tumor;
• ECOG performance status of <=1.

• previous therapy for currently treated colon cancer;
• any evidence of metastatic disease;
• history of other malignancy within last 5 years;
• clinically significant cardiac disease.

This trial will be conducted at the following locations:

• KAZAN 420029
• EKATERINBURG
• IRKUTSK
• TUMEN
• KAZAN
• SMOLENSK
• STAVROPOL
• MOSCOW
• ST PETERSBURG
• OBNINSK
• BARNAUL
• SAMARA
• MOSCOW
• VOLGOGRAD
• TVER
• KOSTROMA
• BELGOROD
• ASTRAKHAN
• IZHEVSK
• KURSK
• RYAZAN
• LIPETSK
• ST PETERSBURG
• SOSHI
• TOMSK
• KRASNODAR
• ROSTOV-NA-DONU
• MOSCOW
• UFA
• UFA
• MOSCOW
• NOVGOROD VELIKY
• MOSCOW
• KALUGA
• MOSCOW
• ARKHANGELSK
• TOLLYATTI
• SURGUT
• ORENBURG
• SALEKHARD
• PERM
• CHELYABINSK
• YUZHNO-SAKHALINSK
• TOMSK