Nasopharyngeal Carcinoma
Conditions
Brief summary
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
Interventions
RADIATIONTOMO
Tomotherapy
RADIATIONIMRT
Intensity modulated radiotherapy
Sponsors
Zhejiang Cancer Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Inclusion criteria
1. Patients with newly histologically confirmed non-keratinizing carcinoma. 2. Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system） 3. Performance status: KPS\>70 4. With normal liver function test (ALT, AST \<1.5ULN) 5. Renal: creatinine clearance \>60ml/min 6. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L. 7. Written informed consent
Exclusion criteria
1. WHO type I squamous cell carcinoma or adenocarcinoma 2. Age \>65 or \<18 3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) 4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) 5. Patient is pregnant or lactating 6. 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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL(quality of life) | 2 years | Changes in quality of life were assessed by EORTC QLQ-C30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS (progression free survival) | 2 years | 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 ). |
| OS (overall survival) | 2 years | from the first day of therapy to death or last follow-up |
| LRRFS(Locoregional failure-free survival) | 2 years | from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit. |
| Adverse Events | 5 years | 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. |
Countries
China
Outcome results
None listed