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
Not provided
The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvant Chemotherapy | Active Comparator | The interventions of adjuvant chemotherapy group is 8 cycles of SOX(S-1+Oxaliplatin) chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. |
|
| Adjuvant Chemo-radiotherapy | Experimental | The interventions of adjuvant chemo-radiotherapy group is concurrent chemo-radiotherapy to be give after 4-6 cycles of chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. Six cycles of SOX chemotherapy to be given. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvant Concurrent Chemo-radiotherapy | Radiation | Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence free survival | 3 years | |
| Distant metastasis free survival | 3 years | |
| Over all survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Li | Contact | +86-87788280 | lee_ak@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese academy of medical sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Adjuvant chemotherapy for active comparator group | Drug | 8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. |
|
| Adjuvant chemotherapy for experimental group | Drug | 6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d. |
|
| 3 years |
| Adverse Event | 3 years |
| 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 |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided