The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.

Detailed Description
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Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results. Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation. Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.

Official Title
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A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathological confirmed squamous cell carcinoma, WHO II-III type, clinical stage II (UICC 7th edition, 2009) Karnovsky performance score > 70 first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer. anticipated life span more than 6 month Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L liver and renal function under the 1.25 normal upper limit with written consent information Exclusion Criteria: have other cancer history have chemotherapy history have radiotherapy history have head and neck surgery history(exclusion lymph node biopsy) evidence showed distant metastasis or other cancer other severe medical comorbidity

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 |
| --- | --- |
| No Intervention: Arm1-radical radiotherapy alone group<br>Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone | |
| Experimental: Arm2-concurrent chemoradiotherapy group<br>Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks. | Drug: cisplatin<br>* in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7<br>* Other names: DDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicities | Acute toxicity will be measured by CTCAE3.0 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term treatment results | 1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal carcinoma, Stage II, Intensity-modulated radiotherapy, Concurrent chemoradiotherapy, Cisplatin