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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT
Intensity modulated radiotherapy is a technique of radiotherapy.
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Failure-free survival (FFS)
The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.
Time frame: One year
Overall survival (OS)
The time is calculated from the date of diagnosis to the date of patient death.
Time frame: 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.
Time frame: 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.
Time frame: One year
Acute and late adverse events
The side effects will be evaluated according to CTCAE V 3.0.
Time frame: Four months
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