Clinical trial NCT02560974: A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer
Official title: A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 1035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m\^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m\^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants greater than or equal to (\>=) 18 years of age
* Gastric adenocarcinoma, Stage II, IIIa or IIIb
* Potentially curative resection of tumor within 6 weeks prior to randomization
* Previously untreated with chemotherapy or radiotherapy

Exclusion Criteria:

* Serious concomitant medical illnesses that would limit life expectancy to less than (\<) 5 years
* Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
* Any evidence of metastatic disease (including presence of tumor cells in the ascites)

Primary outcomes:
measure: Disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
measure: Incidence of adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
city: Beijing
country: China
city: Fujian
country: China
city: Guangzhou
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Tianjin
country: China
city: Bundang City
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Jeollanam-do
country: Korea, Republic of
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: Seoul
country: Korea, Republic of
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: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Changhua
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: