Status:
UNKNOWN
Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Fudan University
Zhejiang Cancer Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the...
Detailed Description
Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent che...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type)
- Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system)
- No evidence of distant metastasis (M0)
- Performance status: KPS ≥70
- With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal)
- Renal: creatinine clearance ≥60ml/min
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL
- Written informed consent
Exclusion
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age ≥70 or \<18
- With a history of renal disease
- Prior malignancy
- Previous chemotherapy or radiotherapy
- Patient is pregnant or lactating
- Unstable cardiac disease requiring treatment.
- Emotion disturbance
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT00677118
Start Date
June 1 2006
End Date
March 1 2015
Last Update
July 12 2013
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060