The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma|
- Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: No ]Acute toxicity will be measured by CTCAE3.0
- Long term treatment results [ Time Frame: 5 years ] [ Designated as safety issue: No ]1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.
|Study Start Date:||July 2010|
|Study Completion Date:||August 2014|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
No Intervention: Arm1-radical radiotherapy alone group
Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone
Experimental: Arm2-concurrent chemoradiotherapy group
Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks.
in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7
Other Name: DDP
Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results.
Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation.
Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187238
|Cancer hospital, Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510060|
|Zhejiang province cancer hospital|
|Hangzhou, Zhejiang, China, 310022|
|Cancer hospital, Chinese Academy of Medical Sciences|
|Beijing, China, 100021|
|Principal Investigator:||Li Gao, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|