TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients
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|ClinicalTrials.gov Identifier: NCT03588403|
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : July 20, 2018
|Condition or disease||Intervention/treatment|
|Nasopharyngeal Carcinoma||Radiation: TOMO Radiation: IMRT|
|Study Type :||Observational|
|Estimated Enrollment :||110 participants|
|Official Title:||Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
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.
Intensity modulated radiotherapy
- QoL(quality of life) [ Time Frame: 2 years ]Changes in quality of life were assessed by EORTC QLQ-C30
- PFS (progression free survival) [ Time Frame: 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) [ Time Frame: 2 years ]from the first day of therapy to death or last follow-up
- LRRFS(Locoregional failure-free survival) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588403
|Hangzhou, Zhejiang, China, 310022|
|Contact: Xiaozhong Chen, MD +86-571-88128202 firstname.lastname@example.org|