Clinical trial NCT02563054: A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer
Official title: An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 75 years of age
* Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

* Uncontrolled infection
* Evidence of central nervous system (CNS) metastases
* History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
* Radiation therapy or major surgery within 4 weeks of study drug
* Previous chemotherapy

Primary outcomes:
measure: Time to disease progression
timeFrame: Up to approximately 7.3 years
Secondary outcomes:
measure: Objective tumor response rate
timeFrame: Up to approximately 7.3 years
measure: Overall survival
timeFrame: Up to approximately 7.3 years
measure: Duration of response
timeFrame: Up to approximately 7.3 years
measure: Time to response
timeFrame: Up to approximately 7.3 years
measure: Incidence of adverse events
timeFrame: Up to approximately 7.3 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Rosario
country: Argentina
city: Tegucigalpa
country: Belize
city: Barretos
country: Brazil
city: Curitiba
country: Brazil
city: Florianopolis
country: Brazil
city: Fortaleza
country: Brazil
city: Porto Alegre
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Beijing
country: China
city: Beijing
country: China
city: Guangdong
country: China
city: Guangdong
country: China
city: Hubei
country: China
city: Jiangsu
country: China
city: Jiangxi
country: China
city: Shandong
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Suzhou
country: China
city: Tianjin
country: China
city: Bogota
country: Colombia
city: Guatemala City
country: Guatemala
city: Hong Kong
country: Hong Kong
city: Hong Kong
country: Hong Kong
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Merida
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico Df
country: Mexico
city: Panama City
country: Panama
city: Callao
country: Peru
city: Lima
country: Peru
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: UFA
country: Russian Federation
city: Montevideo
country: Uruguay
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Chen J, Xiong J, Wang J, Zheng L, Gao Y, Guan Z. Capecitabine/cisplatin versus 5-fluorouracil/cisplatin in Chinese patients with advanced and metastatic gastric cancer: Re-analysis of efficacy and safety data from the ML17032 phase III clinical trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e310-e316. doi: 10.1111/ajco.12832. Epub 2018 Jan 26.