Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Safety and Tolerability of Oxaliplatin-Capecitabine-Trastuzumab Combination and Chemoradiotherapy in Operated Patients With HER-2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma: Phase II Study, TOXAG [ML25574]
Study ID: NCT01748773
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Ankara, , Turkey
Ankara Oncology Hospital; Oncology, Ankara, , Turkey
Baskent University Medical Faculty; Internal Medicine, Ankara, , Turkey
Gaziantep University Medical Faculty, Medical Oncology Department, Gaziantep, , Turkey
Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul, , Turkey
Ege Uni Medical Faculty; Oncology Dept, Izmir, , Turkey
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases, Konya, , Turkey
Bilkent Sehir Hospita; ONKOLOJI, Çankaya/Ankara, , Turkey
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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