Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

Study Overview
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Brief Summary
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Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.

Official Title
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Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Device: Chrono-chemotherapy pump:Melodie
* Device: Routine intravenous drip
* Drug: induction chemotherapy
* Drug: cisplatin chrono-chemotherapy
* Radiation: intensity-modulated radiation therapy
* Drug: cisplatin routine-chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological diagnosis of early cure Ⅲ - Ⅳ stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions; Karnofsky score≥70; Age 18-70 years old, male or female; No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell ≥4．0×109／L，platelet≥100×109 /L. hemoglobin ≥100g/L)，normal liver function (total bilirubin、alanine aminotransferase、 aspartate aminotransferase ≤1.5 times the upper limit of normal)，normal renal function (creatinine ≤1.5 times the upper limit of normal) electrocardiogram does not affect the normal treatment; To understand this study and sign informed consent form. Exclusion Criteria: A distant metastasis; Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study; Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period; Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melodie group<br>Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy | Device: Chrono-chemotherapy pump:Melodie<br> <br> Drug: induction chemotherapy<br> <br> Drug: cisplatin chrono-chemotherapy<br> <br> Radiation: intensity-modulated radiation therapy<br> <br> |
| Other: Routine-chemotherapy group<br>Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy | Device: Routine intravenous drip<br> <br> Drug: induction chemotherapy<br> <br> Radiation: intensity-modulated radiation therapy<br> <br> Drug: cisplatin routine-chemotherapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety |  | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with curative effect |  | 1 year |