Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

Study Overview
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Brief Summary
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The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation. Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen. The third objective of this study is to evaluate who may benifit from this treatment regimen.

Detailed Description
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Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.

Official Title
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Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: docetaxel, cisplatin, fluorouracil
* Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx. Stage Ⅲ, IVa and IVb disease KPS >70 Age between 18-70 Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min. the primary tumor or involved lymph node must be more than 2CM in diameter. No prior radiation treatment to the head and neck or any prior chemotherapy Patients with no prior malignancy (not include basal cell carcinoma of skin) Exclusion Criteria: Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. Prior radiotherapy to the head and neck region for any reason. Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. Pregnant women

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2. | Drug: docetaxel, cisplatin, fluorouracil<br>* neoadjuvant chemotherapy:docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly<br>Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 3 and 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distant metastases free survival , and disease-free survival |  | 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2 Clinical Trial, NPC, neoadjuvant chemotherapy, concurrent chemoradiation