Gastric Cancer, Gastroesophageal Junction Cancer
Conditions
Brief summary
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.
Interventions
DRUGOxaliplatin
Participants will receive oxaliplatin 100 mg/m\^2 IV on Day 1 of Cycles 1-3.
RADIATIONRadiation
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.
DRUGCapecitabine
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.
DRUGTrastuzumab
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).
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Curatively resected HER2+ gastric or gastroesophageal junction adenocarcinoma; HER2+ status as defined by immunohistochemistry-2 positive or 3 positive with corroborative Fluorescence In Situ Hybridization+ result * Participants with stages between Stage IB (T1N1M0) and Stage IIIC * ECOG performance status score equal to or less than (\<=) 2 during screening * Left ventricular ejection fraction equal to or higher than (\>=) 55% with acceptable levels of liver and renal functions * No known contraindication to capecitabine, oxaliplatin, and trastuzumab * No contraindication for radiotherapy or has not received any previous radiotherapy to the gastric region for any reason
Exclusion criteria
* Participants with a malign condition in the last 5 years except squamous cell carcinoma of the skin * Previous neoadjuvant chemotherapy and/or radiotherapy * Any disruption in the physical integrity of the upper gastrointestinal tract (except surgical intervention for gastric or gastroesophageal junction carcinoma) * Known (previously diagnosed and ongoing) malabsorption syndrome * Active gastrointestinal bleeding * Participants with Stage IV gastric or gastroesophageal junction adenocarcinoma * Clinically significant cardiac or cardiovascular disease * Uncontrolled hypertension * Participants who have received any investigational anti-cancer treatment or are being treated in a concomitant investigational drug study * Abnormal laboratory values at screening for serum total bilirubin, alanine aminotransferase or aspartate amino transferase, alkaline phosphatase, absolute neutrophil count, platelet count, and/or hemoglobin * Known or suspected hypersensitivity against trastuzumab or proteins of rodents * Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Month 13 |
| Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score | From Baseline to Month 13 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Disease-Free Survival, Using Response Evaluation Criteria for Solid Tumors (RECIST) | Cycle 1 Day 1 up to tumor relapse or death due to any reason, whichever occurs first (up to 24 months) |
| Overall Survival | Cycle 1 Day 1 up to death due to any reason (up to 24 months) |
Countries
Turkey (Türkiye)
Outcome results
None listed