- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03353467
Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients
Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ming-Yuan Chen, MD,Ph.D
- Phone Number: 86-13903052650
- Email: chmingy@mail.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Sun Yat-sen University Cancer Center
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Sub-Investigator:
- Xiong Zou, PhD.
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Sub-Investigator:
- Rui You, PhD.
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Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital, Sun Yat-sen University
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Guangzhou, Guangdong, China, 528000
- Recruiting
- The First People's Hospital of Foshan
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Contact:
- Jun Tang, MD
- Phone Number: 86-18038860199
- Email: tjun@fsyyy.com
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Zhongshan, Guangdong, China, 528403
- Recruiting
- Zhongshan People's Hospital
-
Contact:
- Feng Lei
- Phone Number: 86-13528227676
- Email: 13528227676@163.com
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Contact:
- Ming-Fang Ji
- Phone Number: 86-13532062222
- Email: jmftbh@aliyun.com
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Guangxi
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Nanning, Guangxi, China, 530021
- Recruiting
- The people's hospital of Guangxi Zhuang Autonomous Region
-
Contact:
- Shen-Hong Qu, MD, PhD
- Phone Number: 86-15807813816
- Email: qshdoctor@163.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Previously untreated, biopsy-proven World Health Organization (WHO) types II or III NPC; Stage I disease (American Joint Committee on Cancer 7th edition); Between 18 and 70 years old; Adequate bone marrow, liver and renal function; Satisfactory performance status: a score of 0 or 1 using the Eastern Cooperative Oncology Group System; Patients provided signed informed consent.
Exclusion Criteria:
- Evidence of relapse or distant metastasis; History of prior malignancy or previous treatment for NPC; The presence of uncontrolled life-threatening diseases; The investigator considered the patient unable to complete the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 3 years
|
The event for overall survival (OS) was death from any cause.
The duration was calculated from the date of treatment initiation to the date of death or last follow-up.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
distant metastasis-free survival
Time Frame: 3 years
|
The event for distant metastasis-free survival (DMFS) was distant metastasis.
The duration was calculated from the date of treatment initiation to the date of distant metastasis or the last follow-up.
|
3 years
|
loco-regional relapse-free survival
Time Frame: 3 years
|
The event for loco-regional relapse-free survival (LRRFS) was loco-regional recurrence.
The duration was calculated from the date of treatment initiation to the date of loco-regional relapse or last follow-up.
|
3 years
|
the rates of complications
Time Frame: 1 year
|
These complications included mucositis, pharyngitis, xerostomia, nasopharyngeal necrosis
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ming-Yuan Chen, MD,Ph.D, Sun Yat-sen University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Carcinoma
- Nasopharyngeal Carcinoma
- Nasopharyngeal Neoplasms
Other Study ID Numbers
- 2017-FXY-055-NPC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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