A Phase 3 interventional study of Gemcitabine and cisplatin in Nasopharyngeal Carcinoma, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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).
Patients with non-keratinizing NPC T1-4N2-3或T3-4N0-1M0 (UICC/AJCC 7th edition) are randomly assigned to receive induction chemotherapy or CCRT alone. Patients in experimental group receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before intensity-modulated radiotherapy (IMRT). Patients in control group receive IMRT concurrently with weekly cisplatin 40 mg/m² up to 7cycles.
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.
Our primary endpoint is failure-free survival (FFS). Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), distant failure-free survival (D-FFS) rates and toxic effects. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
824 studies on the registry are indexed under Nasopharyngeal Carcinoma; 281 are open to participants now.
This study's planned enrollment of 236 is above the median of 84 across 674 interventional studies indexed under Nasopharyngeal Carcinoma.
Browse Nasopharyngeal Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
Induction chemotherapy+IMRT gemcitabine and cisplatin regimen Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT).
Drug: Gemcitabine · Drug: cisplatin · Radiation: Intensity-modulated Radiotherapy
IMRT and concurrent cisplatin Patients receive intensity modulated-radiotherapy (IMRT), concurrently with weekly cisplatin 40 mg/m² up to 7cycles.
Drug: cisplatin · Radiation: Intensity-modulated Radiotherapy
Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
Also known as: DDP
Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.
Also known as: DDP
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.
Also known as: IMRT
Failure-free survival
Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.
Time frame: 2 years
Overall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 2 years
Locoregional failure-free survival
Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
Time frame: 2 years
Distant failure-free survival
Distant failure-free survival is calculated from randomization to the first remote failure.
Time frame: 2 years
Overall response rate
Overall response rate at 3 months after completion of IMRT
Time frame: 3 months after completion of IMRT
Number of participants with adverse events
Incidence of acute and late toxicity
Time frame: 2 years
Quality of life during treatment
Quality of life is measured by FACIT questionnaire.
Time frame: During whole chemotherapy and IMRT treatment.For experimental arm, an expected average of 12 weeks; for active comparator arm, an expected average of 6 weeks.
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gemcitabine