RecruitingNot ApplicableNCT03353467

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


Sponsor

Sun Yat-sen University

Enrollment

228 participants

Start Date

Oct 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether a surgical procedure done through the nose (endoscopic nasopharyngectomy) is a safe and effective treatment for newly diagnosed early-stage nasopharyngeal cancer (cancer at the back of the nose and throat), as an alternative to radiation therapy. **You may be eligible if...** - You have been newly diagnosed with nasopharyngeal cancer confirmed by biopsy (a specific cell type: WHO types II or III) - Your cancer is stage I (early stage, has not spread) - You are between 18 and 70 years old - Your blood counts, liver, and kidney function are adequate - You are in good overall health (performance status 0 or 1) - You are willing and able to give informed consent **You may NOT be eligible if...** - Your cancer has come back or spread to other parts of the body - You have a history of other cancers - You have had previous cancer treatment for this tumor - Your overall health is too poor for the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEndoscopic surgery

Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.

RADIATIONIntensity-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.


Locations(5)

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

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NCT03353467


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