Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
NCT ID: NCT03353467
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
228 participants
INTERVENTIONAL
2017-10-01
2028-10-01
Brief Summary
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With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above.
In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible.
This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group in endoscopic surgery
Stage I patients were only treated with endoscopic surgery without additional chemotherapy. Endoscopic nasopharyngectomy included endoscopic resection , with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
Endoscopic surgery
Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
Group in IMRT
Stage I patients were only treated with radical intensity-modulated radiotherapy without additional chemotherapy. IMRT was delivered with a dynamic multileaf intensity-modulating collimator (NOMOS, Sewickley, PA) by a slice-by-slice arc rotation approach.
Intensity-modulated radiotherapy
All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.
Interventions
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Endoscopic surgery
Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
Intensity-modulated radiotherapy
All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
First People's Hospital of Foshan
OTHER
Zhongshan People's Hospital, Guangdong, China
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Ming-Yuan Chen
Prof.
Principal Investigators
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Ming-Yuan Chen, MD,Ph.D
Role: STUDY_DIRECTOR
Sun Yat-sen University
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The First People's Hospital of Foshan
Guangzhou, Guangdong, China
Zhongshan People's Hospital
Zhongshan, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-FXY-055-NPC
Identifier Type: -
Identifier Source: org_study_id
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