NCT05020067|CompletedPhase 2
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Sponsor study identifier
interventional
90
1 country
1
Study Start
January 12, 2018
Actual (reported)Primary Completion
November 6, 2019
Actual (reported)Study Completion
August 17, 2021
Actual (reported)This is a prospective phase II clinical randomized controlled study, the purpose of this study is to assess whether superficial parotid lobe-sparing intensity-modulated radiotherapy (SPLS-IMRT) can decrease the incidence of xerostomia versus conventional IMRT (C-IMRT) in NPC patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 17, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2018
Actual (reported)November 6, 2019
Actual (reported)August 17, 2021
Actual (reported)August 20, 2021
Actual (reported)August 25, 2021
Actual (reported)the incidence of xerostomia
the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria
12 months
xerostomia questionnaire score
12 months
Salivary flow rate
12 months
locoregional relapse-free survival
36 months
distant metastasis-free survival
36 months
overall survival
36 months
The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%
The entire parotid gland was delineated as an OAR, and V36 (the percentage volume receiving 36 Gy or more) in the entire parotid gland was constrained to be less than 40%
The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Huang H, Miao J, Xiao X, Hu J, Zhang G, Peng Y, Lu S, Liang Y, Huang S, Han F, Deng X, Zhao C, Wang L. Impact on xerostomia for nasopharyngeal carcinoma patients treated with superficial parotid lobe-sparing intensity-modulated radiation therapy (SPLS-IMRT): A prospective phase II randomized controlled study. Radiother Oncol. 2022 Oct;175:1-9. doi: 10.1016/j.radonc.2022.07.006. Epub 2022 Jul 8.
90 participants (actual enrollment reported by the registry).
First Submitted
August 20, 2021
First Posted
August 25, 2021
Study Start
January 12, 2018
Actual (reported)Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Primary Completion
November 6, 2019
Actual (reported)Study Completion
August 17, 2021
Actual (reported)Last Updated
August 25, 2021
Record last verified: 2021-08
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Source: ClinicalTrials.gov.
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