Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

Detailed Description
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For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle. After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.

Official Title
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Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study

Conditions
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Chemoradiation, Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: PF (cisplatin and 5-fluorouracil) group
* Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system) No evidence of distant metastasis(M0) Performance status:KPS>70 With normal liver function test(ALT, AST<1.5ULN) Renal:creatinine clearance >60ml/min Without hematopathy,marrow:WBC>4*109/L, HGB>80G/L, and PLT>100*109/L. With controled blood glucose for diabetes patients Written informed consent Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age>70 or <18 With a history of renal disease Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0 Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating . Peripheral neuropathy Emotional disturbance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF group<br>the group of participants who undergoing cisplatin and 5-fluorouracil(PF)neoadjuvant chemotherapy | Drug: PF (cisplatin and 5-fluorouracil) group<br>* the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.<br>* Other names: Active Comparator group;|
| Experimental: TPF group<br>TPF(docetaxel , cisplatin and 5-fluorouracil)neoadjuvant chemotherapy | Drug: TPF (docetaxel plus cisplatin and 5-fluorouracil) group<br>* 3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours . And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.<br>* Other names: Experiment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progress free survival(PFS) | PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups. | 3 years after the inception assignment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups. | 2 years ,3 years and 5 years after the inception of the assignment | 
| Adverse events | observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemotherapy ,chemoradiation and follow-up. | participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years | 
| local control rate (LCR) |  | 1 year ,2 years,3 years and 5 years after the inception of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma (NPC), cisplatin and 5-fluorouracil (PF), docetaxel,cisplatin and 5-fluorouracil(TPF), Neoadjuvant Chemotherapy, intensity modulated radiotherapy(IMRT)