Brief Title
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma
Official Title
GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma：a Prospective,Parallel, Randomized, Open Labeled, Multicenter Phase III Clinical Trial
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 chemoradiotherapy (CCRT) for locoregionally advanced nasopharyngeal carcinoma( NPC
) patients.
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 combined with concurrent chemoradiotherapy. Patients in both arms
receive radical radiotherapy, and cisplatin (100mg/m²) every three weeks for two cycles
during radiotherapy. Patients in the investigational arm receive gemcitabine (1000 mg/m²
d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles. Patients in the control arm
receive fluorouracil (800mg/m² d1-5) and cisplatin (80mg/m² d1) every 3 weeks for three
cycles. Our primary endpoint is progress-free survival (PFS). Secondary end points include
distant metastasis-free survival (DMFS), overall survival (OS), locoregional relapse-free
survival (LRRFS), initial response rates after treatments, toxic effects and quality of life
(QoL).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
progress-free survival (PFS)
Secondary Outcome
Distant Metastasis-Free Survival (DMFS)
Condition
Nasopharyngeal Carcinoma
Intervention
gemcitabine and cisplatin
Study Arms / Comparison Groups
gemcitabine and cisplatin
Description: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT), concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
468
Start Date
April 3, 2019
Completion Date
February 14, 2026
Primary Completion Date
February 14, 2023
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Ming-Yuan Chen, MD,PhD, +86-20-87343379, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03840421
Organization ID
2018-FXY-140
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study Sponsor
Ming-Yuan Chen, MD,PhD, Principal Investigator, Sun Yat-sen University
Verification Date
October 2020