Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, concurrent chemoradiotherapy, sequential chemoradiotherapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGgemcitabine and cisplatin (Induction and adjuvant chemotherapy)
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.
RADIATIONIMRT
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.
RADIATIONIMRT and concurrent cisplatin
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.
Sponsors
Zhejiang Cancer Hospital
Jiangxi Provincial Cancer Hospital
First Affiliated Hospital of Wenzhou Medical University
Affiliated Hospital of Jiangnan University
Fujian Cancer Hospital
Chaosu Hu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Stratified by stage
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type) * Tumor staged as III-IVA (according to the 8th AJCC edition). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Age between 18 and 65 years old. * Adequate marrow: Neutrophil count ≥2000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN. * 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
* Evidence of distant metastasis * Prior chemotherapy, radiotherapy or surgery (except diagnostic) to primary tumor or nodes. * Other previous or concomitant cancer. * Pregnancy or lactation. * Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, immune deficiency, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or emotional disturbance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure-free survival | 3-year | Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first. |
| Grade III or more mucositis | From the start of radiotherapy to 30 days after radiotherapy | Grade III or more mucositis during radiotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant failure-free survival | 3-year | Distant failure-free survival is calculated from randomization to the first remote failure. |
| Short-term treatment response | Two weeks after completion of induction chemotherapy. Three months after completion of the radiotherapy. | Treatment response after induction chemotherapy, IMRT and completion of treatment. |
| Overall survival | 3-year | Overall survival is calculated from randomization to death from any cause. |
| Quality of Life | up to 3 years | Use EORTC QLQ-HN35. |
| Number of participants with adverse events | up to 3 years | Incidence of acute and late toxicity |
| Locoregional failure-free survival | 3-year | Locoregional failure-free survival is calculated from randomization to the first locoregional failure. |
Countries
China
Contacts
Primary ContactChaosu Hu, MD,PhD
Backup ContactXiayun He, MD
Outcome results
None listed