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Clinical Trials in China / NCT02460887
Active, not recruiting Phase 3

The Role of Induction Gemcitabine and Cisplatin in Locoregionally Advanced Nasopharyngeal Carcinoma in the Era of IMRT

NCT02460887 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2015-06
Last updated
2024-12-03

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

GemcitabinecisplatincisplatinIntensity-modulated Radiotherapy

Gemcitabine: Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.

cisplatin: Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.

cisplatin: Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.

Intensity-modulated Radiotherapy: Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.

Study summary

The purpose of this study is to verify that induction gemcitabine and cisplatin plus intensity-modulated radiotherapy (IMRT) is non-inferior to concurrent weekly cisplatin plus IMRT for patients with locoregionally advanced nasopharyngeal carcinoma (NPC).

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma (including WHO II or III). * Tumor staged as T1-4N2-3或T3-4N0-1M0 (according to the 7th AJCC edition). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. * Adequate liver function: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤1.5×ULN. * Adequate renal function: creatinine clearance ≥ 60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02460887 on ClinicalTrials.gov ↗ ← All trials in China