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The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.
Nasopharyngeal carcinoma (NPC) is endemic in Southern China, Southeast Asia, the Arctic, and mid-East/North Africa. NPC prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. It is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) as standard treatment for NPC.
Recently, the technique of IMRT has become widely used in the treatment of nasopharyngeal carcinoma. The preliminary results showed that IMRT might improve the rate of local control and the quality of life in NPC. In a retrospective study (Ivan,2010), the result showed that IMRT without concurrent chemotherapy provides good outcome for patients with stage IIB NPC with acceptable toxicity. Another study showed that Comparing with IMRT alone, IMRT in combination with chemotherapy provided no significant benefit to locoregionally advanced NPC (Su,2011). With IMRT, it was unclear whether the additional of concurrent chemotherapy was essential for stage II nasopharyngeal carcinoma.
The investigators designed the present study to research the role of adding concurrent chemotherapy to intensity modulated radiotherapy in the treatment of stage II NPC. The primary endpoint is failure-free survival (FFS).The second endpoints were overall survival (OS),loco-regional failure-free survival (LFFS), distant metastasis failure-free survival (DMFS), and acute and late adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent chemoradiotherapy | Experimental | Concurrent chemoradiotherapy: IMRT was given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. |
|
| IMRT alone | Active Comparator | IMRT is given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concurrent chemotherapy with cisplatin | Drug | Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free survival (FFS) | The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The time is calculated from the date of diagnosis to the date of patient death. | One year |
| Loco-regional failure-free survival (LFFS) | The time is calculated from the date of diagnosis to the date of a relapse of local or nodal tumors. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong Zhu, Doctor | Contact | zhuxiaodong83@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21592702 | Background | Yoshizaki T, Ito M, Murono S, Wakisaka N, Kondo S, Endo K. Current understanding and management of nasopharyngeal carcinoma. Auris Nasus Larynx. 2012 Apr;39(2):137-44. doi: 10.1016/j.anl.2011.02.012. Epub 2011 May 17. | |
| 12176778 | Background | Chan AT, Teo PM, Johnson PJ. Nasopharyngeal carcinoma. Ann Oncol. 2002 Jul;13(7):1007-15. doi: 10.1093/annonc/mdf179. |
| Label | URL |
|---|---|
| Guangxi Medical University | View source |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Intensity modulated radiotherapy | Radiation | Intensity modulated radiotherapy is a technique of radiotherapy. |
|
| One year |
| Distant metastasis failure-free survival (DMFS) | The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis. | One year |
| Acute and late adverse events | The side effects will be evaluated according to CTCAE V 3.0. | Four months |
| 21801605 | Background | Su SF, Han F, Zhao C, Huang Y, Chen CY, Xiao WW, Li JX, Lu TX. Treatment outcomes for different subgroups of nasopharyngeal carcinoma patients treated with intensity-modulated radiation therapy. Chin J Cancer. 2011 Aug;30(8):565-73. doi: 10.5732/cjc.010.10547. |
| 20395788 | Background | Tham IW, Lin S, Pan J, Han L, Lu JJ, Wee J. Intensity-modulated radiation therapy without concurrent chemotherapy for stage IIb nasopharyngeal cancer. Am J Clin Oncol. 2010 Jun;33(3):294-9. doi: 10.1097/COC.0b013e3181d2edab. |
| D020266 |
| Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |