The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01187238|
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : September 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: cisplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||August 2014|
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
- Acute toxicities [ Time Frame: 2 years ]Acute toxicity will be measured by CTCAE3.0
- Long term treatment results [ Time Frame: 5 years ]1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|