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| Name | Class |
|---|---|
| JiangXi Province Tumor Hospital | UNKNOWN |
| Fujian Province Tumor Hospital | OTHER |
| SiChuan Province Tumor Hospital | UNKNOWN |
| Hunan Province Tumor Hospital |
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The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT and concurrent cisplatin | Active Comparator | IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction |
|
| IMRT alone | Experimental | IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the beginning the IMRT to 3 year after the end of IMRT |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with severe acute toxicities as assessed by CTCAE v3.0 | From the beginning of IMRT to 3 months after the end of IMRT | |
| Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema |
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Inclusion Criteria:
1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
2.No evidence of distant metastasis
3.More than 1 year from the end of the first course of radiotherapy
4.Male, or female not in the phase of lactating or pregnancy
5.ECOG 0-2
6.Aged 18-70 years old
7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
9.Written informed consort signed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Han, doctor | Contact | 8620-87343030 | hanfei@sysucc.org.cn | |
| hanyu wang, doctor | Contact | 8620-87343418 | wanghany@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WangHanYu | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22209574 | Background | Han F, Zhao C, Huang SM, Lu LX, Huang Y, Deng XW, Mai WY, Teh BS, Butler EB, Lu TX. Long-term outcomes and prognostic factors of re-irradiation for locally recurrent nasopharyngeal carcinoma using intensity-modulated radiotherapy. Clin Oncol (R Coll Radiol). 2012 Oct;24(8):569-76. doi: 10.1016/j.clon.2011.11.010. Epub 2011 Dec 29. | |
| 21509764 |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| OTHER |
| YuNan Province Tumor Hospital | UNKNOWN |
| GuiZhou Province Tumor Hospital | UNKNOWN |
| Hainan Cancer Hospital | OTHER |
| Tongji Hospital | OTHER |
| Second Affiliated Hospital of Nanchang University | OTHER |
| Wuhan University | OTHER |
| First Hospital of FoShan City | UNKNOWN |
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| IMRT | Radiation | Radiation: IMRT IMRT is to give 60Gy in 27 fraction |
|
| From 3 months after the end of IMRT to 1 year after the end of IMRT |
| Xiao WW, Huang SM, Han F, Wu SX, Lu LX, Lin CG, Deng XW, Lu TX, Cui NJ, Zhao C. Local control, survival, and late toxicities of locally advanced nasopharyngeal carcinoma treated by simultaneous modulated accelerated radiotherapy combined with cisplatin concurrent chemotherapy: long-term results of a phase 2 study. Cancer. 2011 May 1;117(9):1874-83. doi: 10.1002/cncr.25754. Epub 2010 Nov 16. |
| 19919887 | Background | Seo Y, Yoo H, Yoo S, Cho C, Yang K, Kim MS, Choi C, Shin Y, Lee D, Lee G. Robotic system-based fractionated stereotactic radiotherapy in locally recurrent nasopharyngeal carcinoma. Radiother Oncol. 2009 Dec;93(3):570-4. doi: 10.1016/j.radonc.2009.10.018. Epub 2009 Nov 16. |
| 26879049 | Result | Guan Y, Liu S, Wang HY, Guo Y, Xiao WW, Chen CY, Zhao C, Lu TX, Han F. Long-term outcomes of a phase II randomized controlled trial comparing intensity-modulated radiotherapy with or without weekly cisplatin for the treatment of locally recurrent nasopharyngeal carcinoma. Chin J Cancer. 2016 Feb 15;35:20. doi: 10.1186/s40880-016-0081-7. |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |