Nasopharyngeal Carcinoma
Conditions
Keywords
induction chemotherapy, nedaplatin, cisplatin, concurrent chemoradiotherapy
Brief summary
To compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma.
Detailed description
This is a prospective, parallel, randomized, open labeled, phase III, non-inferiority clinical trial to compare the effectiveness and toxicity of nedaplatin versus cisplatin in induction chemotherapy combined with concurrent chemoradiotherapy for locoregionally advanced nasopharyngeal carcinoma patients in endemic area - nedaplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with nedaplatin as concurrent chemoradiotherapy (DNF-N) versus cisplatin, docetaxel and fluorouracil as induction chemotherapy regimen combined with cisplatin as concurrent chemoradiotherapy (DPF-P). All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is progress free survival (PFS).
Interventions
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
DRUGNedaplatin
Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
DRUGCisplatin
Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
RADIATIONIntensity 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.
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III 2. Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system 3. No evidence of distant metastasis (M0) 4. Age between 18-65 5. WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l 6. With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln) 7. With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min) 8. Satisfactory performance status: KARNOFSKY scale (KPS) \> 70 9. Patients must give signed informed consent
Exclusion criteria
1. Histologically confirmed keratinizing nasopharyngeal carcinoma (WHO I) 2. Age \>65 or \< 18 years 3. Treatment with palliative intent 4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer 5. History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes 6. History of previous radiotherapy 7. Pregnancy or lactation 8. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progress-Free Survival (PFS) | 3 years | Progress-free survival is calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional Relapse-Free Survival(LRRFS) | 3 years | Relapse-free survival was defined as the time from random assignment to local or regional relapse, or death from any cause. |
| Distant metastasis-Free Survival(DMFS) | 3 years | Distant metastasis-free survival was defined as the time from random assignment to distant metastasis, or death from any cause. |
| Overall Survival(OS) | 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. |
| Objective Response Rate (ORR) | 12 weeks after the interventions | Objective Response Rate (ORR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1) |
| Disease Control Rate (DCR) | 12 weeks after the interventions | Disease Control Rate (DCR) were assessed with nasopharyngeal and neck MRI and flexible nasopharyngoscopy, according to the Response Evaluation Criteria in Solid tumors(version 1.1) |
| Quality of life (QoL) | 3 years | Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for head and neck (EORTC QLQ-H&N35). The EORTC QLQ-H&N35 scale employs a 4-point response format (not at all to very much). Scale scores are transformed to a scale from 0 to 100 according to the EORTC scoring algorithm. For the functioning and the global QoL scale, a higher score indicates better health. For the symptom scales, a higher score indicates a higher level of symptom burden. Either English or Chinese version will be used according to patient's language habits. |
Countries
China
Contacts
Primary ContactJinquan Liu, M.D
Backup ContactBin Qi, M.D
Outcome results
None listed