A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

NCT ID: NCT00502671

Last Updated: 2015-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2012-03-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

capecitabine [Xeloda]

Intervention Type: DRUG

1250mg/m2 po bid on days 1-14 of each 3 week cycle

Interventions

capecitabine [Xeloda]

1250mg/m2 po bid on days 1-14 of each 3 week cycle

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Arkhangelsk, , Russia

Astrakhan, , Russia

Barnaul, , Russia

Belgorod, , Russia

Chelyabinsk, , Russia

Irkutsk, , Russia

Izhevsk, , Russia

Kaluga, , Russia

Kazan', , Russia

Kazan', , Russia

Kirov, , Russia

Kostroma, , Russia

Krasnodar, , Russia

Kursk, , Russia

Lipetsk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Nizhny Novgorod, , Russia

Novgorod Veliky, , Russia

Obninsk, , Russia

Orenburg, , Russia

Perm, , Russia

Rostov-on-Don, , Russia

Ryazan, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Salekhard, , Russia

Samara, , Russia

Sashi, , Russia

Smolensk, , Russia

Stavropol, , Russia

Surgut, , Russia

Tollyatti, , Russia

Tomsk, , Russia

Tomsk, , Russia

Tver', , Russia

Tyumen, , Russia

Ufa, , Russia

Ufa, , Russia

Volgograd, , Russia

Yekaterinburg, , Russia

Yuzhno-Sakhalinsk, , Russia

Countries

Russia

Other Identifiers

ML20592

Identifier Type: -

Identifier Source: org_study_id