Status:
UNKNOWN
The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 nasophar...
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2021
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT01817023
Start Date
April 1 2013
End Date
March 30 2021
Last Update
January 29 2021
Active Locations (6)
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1
Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
2
Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
3
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430030
4
Tongji hospital, Huazhong University of Science & Technology
Wuhan, Hubei, China, 430032