Clinical trial NCT01817023: The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal carcinoma
current chemotherapy
intensity-modulated radiotherapy
low-risk
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2013-03-22
Enrollment: 590
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: Inclusion Criteria:

* Histopathological proven non-keratin nasopharyngeal carcinoma
* AJCC 7th edition stage III/IVM0, without any one of following factors: node size \>6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node \>4 cm
* Life expectancy≥6 months
* Adequate renal function, defined as follows: Serum creatinine \< 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = \[(140 - age) x (wt in kg)\] \[(Serum Cr mg/dl) x (72)\] CCr female = 0.85 x (CCrmale)
* The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin

Exclusion Criteria:

* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated \< 3 years ago
* Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* Severe, active co-morbidity
* Treatment planning does not meet the requirement of prescription dose.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Acute and late toxicities
timeFrame: 5years
measure: 3 year Progression-free survival (PFS)
timeFrame: 5year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tongji hospital, Huazhong University of Science & Technology
state: Hubei
city: Nanchang
country: China
facility: Jiangxi province cancer hospital
state: Jiangxi
city: Beijing
country: China
facility: Cancer hospital, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Li Gao, MD
role: PRINCIPAL_INVESTIGATOR
References: