Impact on Xerostomia for Nasopharyngeal Carcinoma Patients Treated With or Without Superficial Parotid Lobe-sparing Intensity-modulated Radiotherapy
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2018
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2021
CompletedFirst Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 25, 2021
CompletedAugust 25, 2021
August 1, 2021
1.8 years
August 20, 2021
August 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
the incidence of xerostomia
the incidence of xerostomia at 12m post-RT based on Radiation Therapy Oncology Group (RTOG) criteria
12 months
Secondary Outcomes (5)
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
Study Arms (2)
SPLS-IMRT
EXPERIMENTALThe 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%
C-IMRT
NO INTERVENTIONThe 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%
Interventions
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%.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Related Publications (1)
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.
PMID: 35817320DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 25, 2021
Study Start
January 12, 2018
Primary Completion
November 6, 2019
Study Completion
August 17, 2021
Last Updated
August 25, 2021
Record last verified: 2021-08