A Study of Capecitabine (Xeloda) in Combination Chemotherapy Versus Surgery Alone in Participants With Gastric Cancer

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02560974
• Other study ID #: MO17527
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2015
• Last updated: November 1, 2016
• Start date: June 2006
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea, republic of: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1035
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine
Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
• Oxaliplatin
Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival rate		3 years	No
Secondary	Overall survival		5 years	No
Secondary	Incidence of adverse events		5 years	No