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NCT Number: NCT03840421

GP Vs PF As Induction Chemotherapy Combined with CCRT for Locoregionally Advanced Nasopharyngeal Carcinoma

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.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasm Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine and Cisplatin

Drug

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Other names: gemcitabine and cisplatin (GP)

cisplatin and fluorouracil

Drug

Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.

Other names: cisplatin and fluorouracil (PF)

IMRT

Radiation

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

Cisplatin

Drug

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

Other names: cisplatin（DDP）

Primary outcomes

  1. progress-free survival (PFS)

    Time frame: 3 years

    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

Secondary outcomes

  1. Distant Metastasis-Free Survival (DMFS)

    Time frame: 3 years

    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.

  2. Overall Survival (OS)

    Time frame: 3 years

    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. Locoregional Relapse-Free Survival (LRRFS)

    Time frame: 3 years

    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.

  4. Number of participants with adverse events

    Time frame: up to 3 years

    Incidence of acute and late toxicity

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • Guangdong Provincial People's Hospital, China

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2026
Study completion
2028
First posted
Feb 15, 2019
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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