The purpose of this study is to compare the efficacy and safety of sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy +adjuvant chemotherapy) with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of sequential chemoradiotherapy in NPC patients.
Patients with non-keratinizing NPC III-IVA (UICC/AJCC 8th edition) are randomly assigned to receive sequential chemoradiotherapy (induction chemotherapy + intensity-modulated radiotherapy + adjuvant chemotherapy) or induction chemotherapy plus concurrent chemoradiotherapy. Intensity-modulated radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor. The induction or adjuvant chemotherapy is given gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for two cycles. The concurrent chemotherapy is given cisplatin 30 mg/m² every week concurrently with IMRT. Our primary endpoint is failure-free survival(FFS) and grade III mucositis during radiation. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT.
Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor
Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGFailure-free survival
Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.
Time frame: 3-year
Grade III or more mucositis
Grade III or more mucositis during radiotherapy
Time frame: From the start of radiotherapy to 30 days after radiotherapy
Overall survival
Overall survival is calculated from randomization to death from any cause.
Time frame: 3-year
Locoregional failure-free survival
Locoregional failure-free survival is calculated from randomization to the first locoregional failure.
Time frame: 3-year
Distant failure-free survival
Distant failure-free survival is calculated from randomization to the first remote failure.
Time frame: 3-year
Short-term treatment response
Treatment response after induction chemotherapy, IMRT and completion of treatment.
Time frame: Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy.
Number of participants with adverse events
Incidence of acute and late toxicity
Time frame: up to 3 years
Quality of Life
Use EORTC QLQ-HN35.
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Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week.
Time frame: up to 3 years