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This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiotherapy | Experimental | Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42 |
|
| Radiotherapy 60 Gy | Active Comparator | Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy 54 Gy | Radiation | Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 2-year over survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 5 years | |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| the quality of life | assessed with the European Organisation for Research and Treatment of Cancer quality-of-life core questionnaire QLQ-C30 | 5 years |
| the oesophagus-specific quality-of-life | assessed with the European Organisation for Research and Treatment of Cancer quality-of-life the oesophagus-specific questionnaire QLQ-OES18 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MING CHEN, PHD | Zhejiang Cancer Hospital | Study Chair |
| XIANGHUI DU, MD | Zhejiang Cancer Hospital | Principal Investigator |
| youngling JI, MD | Zhejiang Cancer Hospital | Study Director |
| weiguo zhu, MD | Huai'an First People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41893843 | Derived | Ji Y, Fang M, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Wang X, Li P, Wang J, Xu Y, Zheng X, Chen K, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Xu W, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Kong Y, Yu X, Li H, Li R, Huang R, He H, Du X, Chen M. Long-Term Outcomes of Concurrent Chemoradiotherapy With S-1 in Older Patients With Esophageal Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e263541. doi: 10.1001/jamanetworkopen.2026.3541. | |
| 34351356 |
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| ID | Term |
|---|---|
| D004938 | Esophageal 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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| Radiotherapy 60 Gy | Radiation | Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy. |
|
| S-1 | Drug | S-1 70mg/m2 was administered on days 1-14 and 29-42. |
|
| 5 years |
| Derived |
| Ji Y, Du X, Zhu W, Yang Y, Ma J, Zhang L, Li J, Tao H, Xia J, Yang H, Huang J, Bao Y, Du D, Liu D, Wang X, Li C, Yang X, Zeng M, Liu Z, Zheng W, Pu J, Chen J, Hu W, Li P, Wang J, Xu Y, Zheng X, Chen J, Wang W, Tao G, Cai J, Zhao J, Zhu J, Jiang M, Yan Y, Xu G, Bu S, Song B, Xie K, Huang S, Zheng Y, Sheng L, Lai X, Chen Y, Cheng L, Hu X, Ji W, Fang M, Kong Y, Yu X, Li H, Li R, Shi L, Shen W, Zhu C, Lv J, Huang R, He H, Chen M. Efficacy of Concurrent Chemoradiotherapy With S-1 vs Radiotherapy Alone for Older Patients With Esophageal Cancer: A Multicenter Randomized Phase 3 Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1459-1466. doi: 10.1001/jamaoncol.2021.2705. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |