The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Acute and late toxicities [ Time Frame: 5years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||April 2018|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01817023
|Contact: Junlin YI, MDfirstname.lastname@example.org|
|Contact: Kai Wang, MDemail@example.com|
|Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Chong Zhao, MD 8613902206160 firstname.lastname@example.org|
|Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Xiang Guo, MD 8613902251681 email@example.com|
|Tongji hospital, Huazhong University of Science & Technology||Not yet recruiting|
|Wuhan, Hubei, China, 430032|
|Contact: Guoqing Hu, MD 8613707189803 firstname.lastname@example.org|
|Zhongnan Hospital of Wuhan University||Not yet recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Conghua Xie, MD 8613638607566 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 Hospital, Chinese Academy of Medical Sciences|