Nasopharyngeal Carcinoma Clinical Trial
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
Verified date | December 2023 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 468 |
Est. completion date | December 31, 2028 |
Est. primary completion date | August 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University | Affiliated Cancer Hospital & Institute of Guangzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progress-free survival (PFS) | Progress-free survival is calculated from the date of randomization to the date of the first progress at any site. | 3 years | |
Secondary | Distant Metastasis-Free Survival (DMFS) | The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 3 years | |
Secondary | Overall Survival (OS) | The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up. | 3 years | |
Secondary | Locoregional Relapse-Free Survival (LRRFS) | The LRRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit. | 3 years | |
Secondary | Number of participants with adverse events | Incidence of acute and late toxicity | up to 3 years |
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