Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma.

Summary

The goal of this clinical trial is to compare the survival and adverse reactions differences between endoscopic surgery and intensity modulated radiotherapy for patients with newly diagnosed stage Ⅰ nasopharyngeal carcinoma, aiming to verifying the efficacy and safety of endoscopic surgery for stage Ⅰ nasopharyngeal carcinoma.

Conditions

• Nasopharyngeal Carcinoma
• Intensity Modulated Radiotherapy
• Surgery

Interventions

PROCEDURE

Endoscopic nasopharyngectomy followed close follow-up

Radical resection of primary lesion using nasal endoscopy. After the treatment, the electronic nasal endoscopy was reviewed every two weeks to determine the healing of the wound, whether there was tumor recurrence, until the surgical wound was completely healed. The patients were followed up at least once every three months from the first year to the third year, at least once every six months from the fourth year to the fifth year, and at least once every year after five years.

RADIATION

Intensity-modulated Radiotherapy

GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy. After treatment, patients were followed up every 3-6 months from the first year to the third year, every 6-12 months from the fourth year to the fifth year, and at least once a year after five years.

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Fifth Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Huazhong University of Science and Technology Union ShenZhen Hospital (Nanshan Hospital)

  collaborator UNKNOWN

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First People's Hospital of Foshan

  collaborator OTHER

• Zhongshan People's Hospital, Guangdong, China

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Ming-Yuan Chen, MD,PhD · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-25

Primary Completion

2034-03-25

Completion

2034-03-25

Countries

• China

Study Locations