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The purpose of this study is to determine whether raltitrexed concurrent with IMRT is safe, tolerable and effective in the treatment for patients with local-advanced gastric cancer after D0/D1 radical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| postoperative CRT | Experimental | postoperative CRT: Treatment including postoperative radiotherapy (IMRT) with concurrent chemotherapy of Raltitrexed. Radiotherapy will be delivered to a planning target volume with a dose of 45-50.4Gy (1.8-2.0Gy daily) using with Intensity-Modulated Radiotherapy technique. During the radiation treatment, concurrent chemotherapy will be delivered (Raltitrexed, intravenous infusion, 3 mg/m2, on w1 and w4). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Raltitrexed | Drug | concurrent chemotherapy |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of patients occured Grade 3 or higher adverse events | From the first day of the concurrent chemoradiotherapy (CRT) to the 180th day after CRT. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year local-regionally recurrence rate | The probability of locally and/or regionally recurrence at 2 year after CRT on imaging or pathological examination. | 2 year |
| 3-year local-regionally recurrence rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Dai, M.D. | Contact | +86(0)2767813155 | daijing1116@163.com | |
| Ling Xai, M.D. | Contact | +86(0)2767813155 | 22425583@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Fuxiang Zhou, M.D. | Zhongnan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hopital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
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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 |
|---|---|
| C068874 | raltitrexed |
| D018714 | Radiotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
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| postoperative radiotherapy | Radiation | concurrent postoperative radiation therapy |
|
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The probability of locally and/or regionally recurrence at 3 year after CRT on imaging or pathological examination.
| 3 year |
| 2-year disease-free survival probability | The probability of staying free from recurrence at 2 year after CRT on imaging or pathological examination. | 2 year |
| 3-year disease-free survival probability | The probability of staying free from recurrence at 3 year after CRT on imaging or pathological examination. | 3 year |
| 2-year overall survival probability | The probability of staying alive at 2 year after CRT. | 2 year |
| 3-year overall survival probability | The probability of staying alive at 3 year after CRT. | 3 year |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |