TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

Study Overview
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Brief Summary
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Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma

Official Title
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Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: TOMO
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system） 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. Written informed consent Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age >65 or <18 Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A:Tomotherapy<br>Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. | Radiation: TOMO<br>* Tomotherapy<br>|
| Arm B: IMRT<br>Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F. | Radiation: IMRT<br>* Intensity modulated radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL(quality of life) | Changes in quality of life were assessed by EORTC QLQ-C30 | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) | from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ). | 2 years | 
| OS (overall survival) | from the first day of therapy to death or last follow-up | 2 years | 
| LRRFS(Locoregional failure-free survival) | from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit. | 2 years | 
| Adverse Events | Participants will be followed for the duration of hospital stay, an expected average of 50 days and every 3 months thereafter for 5 years. Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE 4.03 during the chemoradiation and follow-up. | 5 years |