The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01817023|
Recruitment Status : Recruiting
First Posted : March 22, 2013
Last Update Posted : September 10, 2014
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Radiation: SIB-IMRT Drug: Cisplatin||Phase 3|
- There were several randomized clinical trials confirmed that concurrent chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC, most of the patients in the trials were treated with conventional radiotherapy technique.
- As the new technique of IMRT used more and more in the clinical practice, the role of concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in terms of overall survival between RT alone and CCRT groups. Furthermore, several large sample size retrospective studies from China, showed that there were no advantage of CCRT over RT alone when treated by SIB-IMRT.
- In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the author divided the locally advanced NPC patients into two groups, with the high-risk group defined as patients met at least one of following criteria: nodal size >6 cm, (2) supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node >4cm.
- Based on these information, we hypothesize that, for low-risk locally advanced NPC patients, there may no need CCRT under SIB-IMRT treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||590 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2018|
Experimental: RT alone
SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
Active Comparator: CCRT group
SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume and cisplatin 100mg/m2 was given at d1, d22,d43 during radiotherapy.
SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volumeDrug: Cisplatin
Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.
- overall survival [ Time Frame: 5 years ]
- Acute and late toxicities [ Time Frame: 5years ]
- compare the acute radiation and chemotherapy-related toxicities during treatment course
- compare late toxicities after treatment
- 3 year Progression-free survival (PFS) [ Time Frame: 5year ]to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
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): NCT01817023
|Contact: Junlin YI, MDfirstname.lastname@example.org|
|Contact: Kai Wang, MDemail@example.com|
|Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Xiang Guo, MD 8613902251681 firstname.lastname@example.org|
|Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Chong Zhao, MD 8613902206160 email@example.com|
|Zhongnan Hospital of Wuhan University||Not yet recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Conghua Xie, MD 8613638607566 firstname.lastname@example.org|
|Tongji hospital, Huazhong University of Science & Technology||Recruiting|
|Wuhan, Hubei, China, 430032|
|Contact: Guoqing Hu, MD 8613707189803 email@example.com|
|Jiangxi province cancer hospital||Not yet recruiting|
|Nanchang, Jiangxi, China, 330029|
|Contact: Jingao Li, MD 8613970866296 firstname.lastname@example.org|
|Cancer hospital, Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Junlin YI, MD 861087788504 email@example.com|
|Principal Investigator:||Li Gao, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|