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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Tomotherapy | 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. |
| |
| Arm B: IMRT | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOMO | Radiation | Tomotherapy |
| |
| IMRT |
| Measure | Description | Time Frame |
|---|---|---|
| QoL(quality of life) | Changes in quality of life were assessed by EORTC QLQ-C30 | 2 years |
| 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) |
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Inclusion Criteria:
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.
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nasopharyngeal carcinoma patients staged T1-4N0-3M0
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaozhong Chen | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Radiation |
Intensity modulated radiotherapy |
|
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 |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |