Trial information
A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
Status: Recruiting
Protocol number: ML20592
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific 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. Target sample size is 300.
Study phase: IV
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. SAEs, AEs, laboratory parameters. Time frame: Week 24
Key secondary outcomes: None Time frame: None
Inclusion criteria:
- adult patients, >=18 years of age;
- colon cancer (Dukes stage C);
- surgery, with no evidence of remaining tumor;
- ECOG performance status of <=1.
Exclusion criteria:
- previous therapy for currently treated colon cancer;
- any evidence of metastatic disease;
- history of other malignancy within last 5 years;
- clinically significant cardiac disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 06/22/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Russian Federation
- Arkhangelsk
- Astrakhan
- Barnaul
- Belgorod
- Chelyabinsk
- Ekaterinburg
- Irkutsk
- Izhevsk
- Kaluga
- Kazan
- Kostroma
- Krasnodar
- Kursk
- Lipetsk
- Moscow
- Novgorod Veliky
- Obninsk
- Orenburg
- Perm
- Rostov-Na-Donu
- Ryazan
- Salekhard
- Samara
- Smolensk
- Soshi
- St Petersburg
- Stavropol
- Surgut
- Tollyatti
- Tomsk
- Tver
- Ufa
- Volgograd
- Yuzhno-Sakhalinsk
