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The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
DRAGON SENILE research, Neoadjuvant Chemotherapy plus Surgery versus surgery first for elderly Gastric Cancer patients, is an investigator-initiated; phase II/III, open-label, randomized controlled study. The main purpose of this study is to compare the feasibility and efficacy of neoadjuvant chemotherapy (modified SOX) for elderly patients with locally advanced gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NAC PLUS SURGERY | Experimental | Patients receive three cycles of the modified dose of TGO plus oxaliplatin before curative gastrectomy. |
|
| SURGERY FIRST | Active Comparator | Patients undergo curative gastrectomy without any prior chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from randomization to death from any cause | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Completion rate of planned NAC | Completion rate of planned chemotherapy before surgery. | Three months |
| Percentage of Grade 3/4 hematological adverse events | Percentage of Grade 3/4 hematological adverse events during neoadjuvant chemotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Birendra K Sah | Contact | 0086-21-64370045 | 6701302 | rjsurgeon@hotmail.com |
| Zhenggang Zhu | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Zhenggang Zhu | Ruijin Hospital | Study Chair |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Curative gastrectomy | Procedure | Radical gastrectomy with D2 lymph node dissection |
|
| Three months |
| Pathological response | Total percentage of patients with pathological complete tumor regression (TRG1a) and sub-total tumor regression (TRG1b) in the primary tumor | Four months |
| Disease-free survival (DFS) | Time from randomization to relapse of the disease | Two years |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |