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 study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine + Oxaliplatin | Experimental | Patients will receive oral capecitabine (1000 mg/m^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months). |
|
| Observation | No Intervention | Participants will not receive any treatment but will be seen regularly by a physician. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival rate | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Incidence of adverse events | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100044 | China | ||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxaliplatin | Drug | Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles. |
|
| Beijing |
| 100142 |
| China |
| Fujian | 350001 | China |
| Guangzhou | 510060 | China |
| Guangzhou | 510080 | China |
| Shanghai | 200025 | China |
| Shanghai | 200032 | China |
| Shenyang | 110001 | China |
| Tianjin | 300060 | China |
| Bundang City | 463-802 | South Korea |
| Busan | 49267 | South Korea |
| Daegu | 700-712 | South Korea |
| Daegu | 702-210 | South Korea |
| Daegu | South Korea |
| Gyeonggi-do | 10408 | South Korea |
| Gyeonggi-do | 443-380 | South Korea |
| Incheon | 405-760 | South Korea |
| Jeollabuk-do | 561-712 | South Korea |
| Jeollanam-do | 58128 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 120-752 | South Korea |
| Seoul | 130-872 | South Korea |
| Seoul | 134-791 | South Korea |
| Seoul | 135-720 | South Korea |
| Seoul | 139-709 | South Korea |
| Seoul | 140-743 | South Korea |
| Seoul | 152-703 | South Korea |
| Seoul | 158-710 | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Changhua | 500 | Taiwan |
| Tainan | 704 | Taiwan |
| Taipei | 00112 | Taiwan |
| Taipei | 104 | Taiwan |
| Taipei | Taiwan |
| Taoyuan | 333 | Taiwan |
| 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 |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided