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 (TOXAG)
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|ClinicalTrials.gov Identifier: NCT01748773|
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Gastroesophageal Junction Cancer||Drug: Oxaliplatin Radiation: Radiation Drug: Capecitabine Drug: Trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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]|
|Actual Study Start Date :||January 29, 2013|
|Actual Primary Completion Date :||August 21, 2015|
|Actual Study Completion Date :||June 15, 2017|
Experimental: Combination Therapy
Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation.
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).
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748773
|Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology|
|Adana, Turkey, 01250|
|Ankara Numune Hospital; Onkoloji|
|Ankara, Turkey, 06100|
|Ankara Oncology Hospital; Oncology|
|Ankara, Turkey, 06200|
|Baskent University Medical Faculty; Internal Medicine|
|Ankara, Turkey, 06490|
|Gaziantep University Medical Faculty, Medical Oncology Department|
|Gaziantep, Turkey, 27310|
|Marmara Uni Faculty of Medicine; Medical Oncology|
|Istanbul, Turkey, 34890|
|Ege Uni Medical Faculty; Oncology Dept|
|Izmir, Turkey, 35100|
|Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases|
|Konya, Turkey, 42080|
|Hacettepe Uni Medical Faculty Hospital; Oncology Dept|
|Sıhhiye, ANKARA, Turkey, 06100|
|Study Director:||Clinical Trials||Hoffmann-La Roche|