This single-arm, open-label study will evaluate the safety and efficacy of the combination oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in participants with curatively resected HER2+ gastric or gastroesophageal junction cancer. Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin 100 milligrams per square meter (mg/m\^2) IV on Day 1 of Cycles 1-3, and capecitabine 850 mg/m\^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25 doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time on study treatment is 1 year plus a 1-year follow-up period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Participants will receive oxaliplatin 100 mg/m\^2 IV on Day 1 of Cycles 1-3.
Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.
Participants will receive capecitabine 850 mg/m\^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Ankara, Turkey (Türkiye)
Ankara Oncology Hospital; Oncology
Ankara, Turkey (Türkiye)
Baskent University Medical Faculty; Internal Medicine
Ankara, Turkey (Türkiye)
Bilkent Sehir Hospita; ONKOLOJI
Çankaya/Ankara, Turkey (Türkiye)
Gaziantep University Medical Faculty, Medical Oncology Department
Gaziantep, Turkey (Türkiye)
Marmara Uni Faculty of Medicine; Medical Oncology
Istanbul, Turkey (Türkiye)
Ege Uni Medical Faculty; Oncology Dept
Izmir, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
Konya, Turkey (Türkiye)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Month 13
Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score
Time frame: From Baseline to Month 13
Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST)
Time frame: Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months)
Overall Survival
Time frame: Cycle 1 Day 1 up to death due to any reason (up to 24 months)
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