Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Based on the radiobiological findings that accelerated tumor repopulation in nasopharyngeal carcinoma occurs in the late-course of radiation therapy, the investigators hypothesize that intensity-modulated radiation therapy(IMRT) with concomitant boost schedule by increasing daily dose starting at the fifth week after initiation of IMRT might improve tumor control and decrease treatment toxicities for locoregionally advanced nasopharyngeal carcinoma. The study is designed to test if late-course accelerated hyperfractionated IMRT can improve the outcomes as compared with conventionally fractionated IMRT in newly diagnosed patients with locoregionally advanced nasopharyngeal carcinoma.

Official Title
-----------------
Late-Course Accelerated Hyperfractionated IMRT Versus Conventionally Fractionated IMRT in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Randomized Clinical Trial

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

Intervention / Treatment
-----------------
* Radiation: Late-course accelerated hyperfractionated IMRT
* Drug: Concomitant cisplatin chemotherapy
* Radiation: Conventionally fractionated IMRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven non-keratinizing or undifferentiated type nasopharyngeal carcinoma for primary treatment with curative intent According to AJCC 2002 Staging System, clinical stage must be Ⅱb-Ⅳb Age between 18-70 Karnofsky performance status ≥70 WBC ≥4,000/mm3, PLT ≥ 100,000/mm3,serum creatinine ≤ 1.6 mg/dl Without radiotherapy or chemotherapy Signed study-specific consent form prior to study entry Exclusion Criteria: Patients with distant metastasis Pregnant or lactating women The presence of uncontrolled life-threatening illness Patients who received radiotherapy or chemotherapy previously

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Late-course accelerated hyperfractionated IMRT with concomitant cisplatin chemotherapy | Radiation: Late-course accelerated hyperfractionated IMRT<br>* IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Six-week treatment: PTV1=60Gy/30fractions, PTV2=57Gy/30fractions,PTV3=54Gy/30fractions.(2) Concomitant boost to PTV1 as a second daily treatment for the last 10 treatments of the Six-week treatment: PTV1=12Gy/10fractions.(3) PTV3 will be treated with conventional radiotherapy technique separately.<br>Drug: Concomitant cisplatin chemotherapy<br>* cisplatin:40mg/m2 weekly infusion for 6 weeks<br>|
| Other: B<br>Conventionally fractionated IMRT with concomitant cisplatin chemotherapy | Drug: Concomitant cisplatin chemotherapy<br>* cisplatin:40mg/m2 weekly infusion for 6 weeks<br>Radiation: Conventionally fractionated IMRT<br>* IMRT target definition: PTV1=Gloss tumor PTV; PTV2=High risk area containing subclinical disease; PTV3=Low risk area containing subclinical disease IMRT delivery scheduling: (1) Seven-week treatment: PTV1=70Gy/35fractions, PTV2=63Gy/35fractions,PTV3=55.8Gy/31fractions.(2) PTV3 will be treated with conventional radiotherapy technique separately.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local/regional control rate, Acute and late toxicities |  | 2-Yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate |  | 5-Yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal carcinoma, Locally advanced disease, Intensity-modulated radiation therapy, Accelerated hyperfractionation, Concomitant boost radiation therapy, Concurrent chemotherapy