Status:
ACTIVE_NOT_RECRUITING
GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
First Affiliated Hospital, Sun Yat-Sen University
Guangdong Provincial People's Hospital, China
Conditions:
Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the survival and toxicity of GP (gemcitabine and cisplatin) vs. PF (cisplatin and fluorouracil) as induction chemotherapy combined with concurrent chemoradiothe...
Detailed Description
Patients presented with non-keratinizing NPC and stage T1-4N2-3/T4N0-1M0 are randomly assigned to receive GP (gemcitabine and cisplatin) or PF (cisplatin and fluorouracil) induction chemotherapy combi...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- Tumor staged as T1-4N2-3/T4N0-1M0（according to the 8th AJCC edition）
- Male and no pregnant female
- Age between 18-65
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<2.0×upper limit of normal (ULN)
- Adequate renal function: creatinine clearance ≥60 ml/min
- Satisfactory performance status: Karnofsky scale (KPS) ≥ 70
- Without radiotherapy or chemotherapy
- Patients must give signed informed consent
Exclusion
- Evidence of relapse or distant metastasis
- History of prior malignancy or previous treatment for NPC
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
- Pregnancy or lactation
Key Trial Info
Start Date :
April 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT03840421
Start Date
April 3 2019
End Date
December 31 2028
Last Update
January 13 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060