A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer
- Conditions
- Gastric CancerGastroesophageal Junction Cancer
- Interventions
- Registration Number
- NCT01748773
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Combination Therapy Trastuzumab Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation. Combination Therapy Oxaliplatin Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation. Combination Therapy Radiation Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation. Combination Therapy Capecitabine Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
- Primary Outcome Measures
Name Time Method Change from Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status Score From Baseline to Month 13 Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline up to Month 13
- Secondary Outcome Measures
Name Time Method Overall Survival Cycle 1 Day 1 up to death due to any reason (up to 24 months) 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)
Trial Locations
- Locations (9)
Marmara Uni Faculty of Medicine; Medical Oncology
🇹🇷Istanbul, Turkey
Baskent University Medical Faculty; Internal Medicine
🇹🇷Ankara, Turkey
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
🇹🇷Adana, Turkey
Ankara Oncology Hospital; Oncology
🇹🇷Ankara, Turkey
Ege Uni Medical Faculty; Oncology Dept
🇹🇷Izmir, Turkey
Bilkent Sehir Hospita; ONKOLOJI
🇹🇷Çankaya/Ankara, Turkey
Gaziantep University Medical Faculty, Medical Oncology Department
🇹🇷Gaziantep, Turkey
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
🇹🇷Konya, Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
🇹🇷Ankara, Turkey