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Gastric cancer is one of the most common malignant tumors in China, and the incidence and mortality rate are second in malignant tumors. The treatment of gastric cancer need integrated multidisciplinary treatment, and surgery is the only possible curative method for gastric cancer at present. Previous studies have reported that neoadjuvant chemoradiotherapy can downstage primary tumor to increase radical resection rate in order to improve the long-term prognosis of advanced gastric cancer. However, there is no study on the application of hypo-radiotherapy to neoadjuvant radiotherapy in gastric cancer. The aim of this study was to observe the maximum tolerated dose (MTD) and dose limited toxicity (DLT) of hypo-fractionated radiotherapy for locally advanced gastric cancer.
After enrolled in this study, the patient was first treated with radiotherapy, concurrent with oral S-1 80mg/m2/day, on radiotherapy days. 3 weeks after the end of radiotherapy, patients treated with neoadjuvant chemotherapy with oxaliplatin and S-1. Oxaliplatin is given on dose of 130mg/m2 iv on day 1; S-1 on 40-60mg po BID on day 1-14, oral. Imaging evaluation was performed 3 weeks after neoadjuvant treatment. The radical operation and surgical procedure were determined on MDT discussion. Non-operable patients continue with 3 cycles of chemotherapy, and the chemotherapy regimen can be changed. A 3 cycle of SOX adjuvant chemotherapy was performed after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypo-fractionated radiotherapy | Experimental | Hypo-fractionated neoadjuvant radiotherapy concurrent with S1 chemotherapy for local advanced gastric cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypo-fractionated radiotherapy | Radiation | Hypo-fractionated radiotherapy with fraction >2Gy . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose AND Dose limited toxicity | To assess maximum tolerated dose and dose limited toxicity of hypo-fractionated neoadjuvant radiotherapy | From date of enrollment until one month after chemo-radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | To evaluate the pathological response rate of gastric cancer after hypo-fractionated neoadjuvant radiotherapy | From date of enrollment until surgery, assessed up to 2 months |
| 2-year disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Jin, MD | Contact | 8610-87787658 | jinjing1025@csco.org.cn | |
| Ning Li, MD | Contact | 8610-87787625 | lee_ak@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, Chinese academy of medical sciences | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35219300 | Derived | Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7. | |
| 30089457 |
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There is no plan to make individual participant data (IPD) available to other researchers.
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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 |
|---|---|
| C079198 | S 1 (combination) |
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| S1 | Drug | S-1 80mg/m2/day, orally intake on radiotherapy days. |
|
To evaluate the 2-year disease-free survival of gastric cancer after hypo-fractionated neoadjuvant radiotherapy
| From date of enrollment until the date of first documented progression or date of relapse, whichever came first, assessed up to 24 months |
| Derived |
| Li N, Wang X, Tang Y, Zhao D, Chi Y, Yang L, Jiang L, Jiang J, Liu W, Tang Y, Fang H, Liu Y, Song Y, Wang S, Jin J, Li Y. A prospective phase I study of hypo-fractionated neoadjuvant radiotherapy for locally advanced gastric cancer. BMC Cancer. 2018 Aug 8;18(1):803. doi: 10.1186/s12885-018-4707-9. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |