Clinical trial NCT00502671: A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
timeFrame: Up to 25 weeks (from Baseline to the end of safety follow-up)
Secondary outcomes:
measure: Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE
timeFrame: Up to 25 weeks (from Baseline to the end of safety follow-up)
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
city: Astrakhan
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Belgorod
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kaluga
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kazan
country: Russian Federation
city: Kirov
country: Russian Federation
city: Kostroma
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Kursk
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novgorod Veliky
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Perm
country: Russian Federation
city: Rostov-na-donu
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Salekhard
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Soshi
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Surgut
country: Russian Federation
city: Tollyatti
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tumen
country: Russian Federation
city: Tver
country: Russian Federation
city: UFA
country: Russian Federation
city: UFA
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Yuzhno-Sakhalinsk
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: