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As stereotactic radiotherapy (SBRT) has been widely used in clinical practice at present, the aim of this study is to evaluate the efficacy and safety of stereotactic body radiation therapy compared with intensity modulated radiation therapy (IMRT) concurrently with EP regimen(cisplatin plus etoposide) in treating patients with limited-stage small cell lung cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1 | Experimental | SBRT plus EP |
|
| GROUP 2 | Active Comparator | IMRT plus EP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | 40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From date of randomization until last survival confirm date or date of death from any cause, whichever came first, assessed up to 3 years | |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueqin Yang, PHD | Contact | 86-23-68757151 | yangxueqin@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xueqin Yang, PHD | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daping Hospital, Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25416052 | Background | Li C, Xiong Y, Zhou Z, Peng Y, Huang H, Xu M, Kang H, Peng B, Wang D, Yang X. Stereotactic body radiotherapy with concurrent chemotherapy extends survival of patients with limited stage small cell lung cancer: a single-center prospective phase II study. Med Oncol. 2014 Dec;31(12):369. doi: 10.1007/s12032-014-0369-x. Epub 2014 Nov 22. | |
| 9920950 |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| IMRT | Radiation | 45 Gy for each patient,Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks. |
|
| EP | Drug | Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal. |
|
| the first date of treatment to 3 months after the last dose of study drug |
| Tumor response rate | the ratio between the number of responders and number of patients assessable for tumor response,assessed up to 1 years |
| Turrisi AT 3rd, Kim K, Blum R, Sause WT, Livingston RB, Komaki R, Wagner H, Aisner S, Johnson DH. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. doi: 10.1056/NEJM199901283400403. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |