Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID03353467

A Prospective Clinical Trial of Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Led by Sun Yat-sen University · Updated on 2021-06-03

228

Participants Needed

5

Research Sites

156 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

F

First Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Nasopharyngeal carcinoma (NPC) is most common in eastern Asia, especially among the Cantonese population in Guangdong. Radiotherapy is the standard initial treatment because NPC is sensitive to radiation and located deep in the body. Although radiotherapy has good results, it can cause serious side effects. Surgery is usually for recurrent NPC, but traditional open surgery has many complications and limited success in removing tumors. With advances in surgical techniques, especially the use of electronic endoscopic systems, endoscopic nasopharyngectomy may address these issues. Previous analysis of 9 patients with stage I NPC treated with this surgery showed promising survival rates, suggesting it is a feasible option for early-stage disease. This study compares two treatments for newly diagnosed stage I NPC patients: endoscopic nasopharyngectomy surgery and radical intensity-modulated radiotherapy (IMRT). Endoscopic surgery involves removing the tumor through an endoscope, sometimes using a nasal mucoperiosteal flap to cover defects. The radiotherapy group receives IMRT delivered with a specialized device that targets the tumor precisely. Stage I patients receive only one of these treatments without additional chemotherapy. Participants will be monitored for survival outcomes over 3 years, including overall survival, distant metastasis-free survival, and loco-regional relapse-free survival. Complication rates will also be tracked for 1 year. The study assesses quality of life alongside these outcomes. The total participation period covers treatment and follow-up visits to evaluate patient health and treatment effects under medical supervision.

CONDITIONS

Brief Title

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Previously untreated, biopsy-proven World Health Organization (WHO) types II or III nasopharyngeal carcinoma
  • Stage I disease according to American Joint Committee on Cancer 7th edition
  • Age between 18 and 70 years
  • Adequate bone marrow, liver, and kidney function
  • Eastern Cooperative Oncology Group performance status score of 0 or 1
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • Evidence of relapse or distant metastasis
  • History of prior malignancy or previous treatment for nasopharyngeal carcinoma
  • Presence of uncontrolled life-threatening diseases
  • Investigator judgment that patient is unable to complete the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 to 2 weeks depending on treatment type

Participants receive treatment for Stage I nasopharyngeal carcinoma either through endoscopic nasopharyngectomy surgery or intensity-modulated radiotherapy (IMRT).

1 to 2 visits depending on treatment assignment

Follow-up

Duration - Up to 3 years

Participants are monitored for survival, cancer recurrence, and complications after treatment.

Regular follow-up visits during the 3 years

Trial Site Locations

Total: 5 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China, 510080

Actively Recruiting

3

The First People's Hospital of Foshan

Guangzhou, Guangdong, China, 528000

Actively Recruiting

4

Zhongshan People's Hospital

Zhongshan, Guangdong, China, 528403

Actively Recruiting

5

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China, 530021

Actively Recruiting

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Research Team

M

Ming-Yuan Chen, MD,Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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