Brief Title
TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients
Official Title
Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study
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
Study Type
Observational
Primary Outcome
QoL(quality of life)
Secondary Outcome
PFS (progression free survival)
Condition
Nasopharyngeal Carcinoma
Intervention
TOMO
Study Arms / Comparison Groups
Arm A:Tomotherapy
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
110
Start Date
July 1, 2018
Completion Date
July 31, 2022
Primary Completion Date
July 31, 2022
Eligibility Criteria
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. -
Gender
All
Ages
18 Years - 65 Years
Contacts
, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03588403
Organization ID
IRB-2018-133
Responsible Party
Principal Investigator
Study Sponsor
Zhejiang Cancer Hospital
Study Sponsor
, ,
Verification Date
July 2018