NCT01748773 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 29, 2013

Primary Completion Date

August 21, 2015

Study Completion Date

June 15, 2017

Conditions

Gastric CancerGastroesophageal Junction Cancer

Interventions

DRUG

Oxaliplatin

Participants will receive oxaliplatin 100 mg/m\^2 IV on Day 1 of Cycles 1-3.

RADIATION

Radiation

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.

DRUG

Capecitabine

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.

DRUG

Trastuzumab

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).

Trial Locations (9)

27310

Gaziantep University Medical Faculty, Medical Oncology Department, Gaziantep

34890

Marmara Uni Faculty of Medicine; Medical Oncology, Istanbul

35100

Ege Uni Medical Faculty; Oncology Dept, Izmir

42080

Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases, Konya

01250

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana

06100

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Ankara

06200

Ankara Oncology Hospital; Oncology, Ankara

06490

Baskent University Medical Faculty; Internal Medicine, Ankara

06800

Bilkent Sehir Hospita; ONKOLOJI, Çankaya/Ankara

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY