Nedaplatin in Treatment for Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

Detailed Description
-----------------
This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Official Title
-----------------
Induction Chemotherapy With Nedaplatin, Docetaxel and 5-Fluorouracil Followed by Concurrent Nedaplatin and Radiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Single Arm, Open Label, Multicenter, Phase II Clinical Study.

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Docetaxel, nedaplatin, fluorouracil
* Radiation: IMRT
* Drug: Nedaplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system No evidence of distant metastasis (M0) Age between 18-65 WBC≥4×10^9/ l, platelet ≥ 100×10^9/ l and hemoglobin ≥ 90g/l With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln) With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min) Satisfactory performance status: KARNOFSKY scale (KPS) > 70 Patients must give signed informed consent Exclusion Criteria: Treatment with palliative intent The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes) Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes History of previous radiotherapy Pregnancy or lactation 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DNF-N<br>Induction chemotherapy: three cycles of intravenous docetaxel 60 mg/m² on day 1, intravenous nedaplatin 60 mg/m² on day 1, and continuous intravenous fluorouracil 600 mg/m² per day from day 1 to day 5, every 3 weeks Concurrent chemoradiotherapy: three cycles of 100 mg/m² nedaplatin every 3 weeks, concurrently with intensity-modulated radiotherapy Radiotherapy: radical intense modulated radiation therapy | Drug: Docetaxel, nedaplatin, fluorouracil<br>* 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.<br>* Other names: DNF;Radiation: IMRT<br>* 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.<br>* Other names: RT;Drug: Nedaplatin<br>* Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.<br>* Other names: N;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate (ORR) | CR+PR | at the end of radiotherapy(±1week） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival(OS) | The OS was defined as the duration from the date of beginning of treatment to the date of death from any cause or censored at the date of the last follow-up. | 3 years | 
| Progress-Free Survival (PFS) | Progress-free survival is calculated from the date of beginning of treatment to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first. | 3 years | 
| Locoregional Relapse-Free Survival(LRRFS) | Relapse-free survival was defined as the time from beginning of treatment to local or regional relapse, or death from any cause. | 3 years | 
| Distant metastasis-Free Survival(DMFS) | Distant metastasis-free survival was defined as the time from beginning of treatment to distant metastasis, or death from any cause. | 3 years | 
| Quality of life (QoL) | 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. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induction chemotherapy, Nedaplatin, Concurrent chemoradiotherapy, Nasopharyngeal Carcinoma