Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy | Experimental | Participants will receive combination therapy comprising of trastuzumab, oxaliplatin, capecitabine, and radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin | Drug | Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3. |
|
| Measure | Description | 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 |
| Measure | Description | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | 01250 | Turkey (Türkiye) | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33979100 | Derived | Abali H, Yalcin S, Onal HC, Dane F, Oksuzoglu B, Ozdemir N, Mertsoylu H, Artac M, Camci C, Karabulut B, Basal FB, Budakoglu B, Sendur MAN, Goktas B, Ozdener F, Baygul A. A Phase II Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab and Chemoradiotherapy in the Adjuvant Setting in Operated Patients With HER2-positive Gastric or Gastroesophageal Junction Cancer (TOXAG Study): A Turkish Oncology Group Study. Am J Clin Oncol. 2021 Jul 1;44(7):301-307. doi: 10.1097/COC.0000000000000825. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Capecitabine | Drug | 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. |
|
| Trastuzumab | Drug | 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). |
|
| Hacettepe Uni Medical Faculty Hospital; Oncology Dept |
| Ankara |
| 06100 |
| Turkey (Türkiye) |
| Ankara Oncology Hospital; Oncology | Ankara | 06200 | Turkey (Türkiye) |
| Baskent University Medical Faculty; Internal Medicine | Ankara | 06490 | Turkey (Türkiye) |
| Bilkent Sehir Hospita; ONKOLOJI | Çankaya/Ankara | 06800 | Turkey (Türkiye) |
| Gaziantep University Medical Faculty, Medical Oncology Department | Gaziantep | 27310 | Turkey (Türkiye) |
| Marmara Uni Faculty of Medicine; Medical Oncology | Istanbul | 34890 | Turkey (Türkiye) |
| Ege Uni Medical Faculty; Oncology Dept | Izmir | 35100 | Turkey (Türkiye) |
| Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases | Konya | 42080 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D011827 | Radiation |
| D000069287 | Capecitabine |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided