GP vs PF as Induction Chemotherapy Combined With CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03840421
• Other study ID #: 2018-FXY-140
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 3, 2019
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasm
• Head and Neck Neoplasms
• Nasopharyngeal Carcinoma
• Nasopharyngeal Diseases
• Nasopharyngeal Neoplasms
• Neoplasms

Intervention

Drug:
• gemcitabine and cisplatin
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
• cisplatin and fluorouracil
Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Radiation:
• IMRT
Intensity modulated-radiotherapy (IMRT) is given as 30~33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68~70 Gy to the primary tumor

Drug:
• cisplatin
IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (4)

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

Country where clinical trial is conducted

China, 

Outcome

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