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Clinical Trials in China / NCT03353467
Recruiting Not applicable

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

NCT03353467 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2017-10-01
Last updated
2021-06-03

Condition(s) studied

Nasopharyngeal CarcinomaEndoscopic SurgeryPrimary Napharyngeal CarcinamaStage I Nasopharyngeal Cancer

Investigational drug(s) / intervention(s)

Endoscopic surgeryIntensity-modulated radiotherapy

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
The First Affiliated Hospital, Sun Yat-Sen University Guangzhou Guangdong Recruiting
The First People's Hospital of Foshan Guangzhou Guangdong Recruiting
Zhongshan People's Hospital Zhongshan Guangdong Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region Nanning Guangxi Recruiting

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03353467 on ClinicalTrials.gov ↗ ← All trials in China