Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06529562

Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.

Led by Ming-Yuan Chen · Updated on 2024-07-31

384

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

Sponsors

M

Ming-Yuan Chen

Lead Sponsor

F

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .

CONDITIONS

Official Title

Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Performance Status Score 0-1 points
  • Histologically or cytologically confirmed non-keratinized nasopharyngeal carcinoma (WHO type II or III)
  • Surgically resectable primary nasopharyngeal lesions including T1, T2, T3 with tumor diameter ≤1.5cm
  • Resectable retropharyngeal lymph nodes ≤1.5cm diameter with intact tissue space and no extranodal invasion
  • Resectable cervical lymph nodes ≤3cm diameter, above lower edge of cricoid cartilage, moderately mobile, no extranodal invasion
  • Clinical stage T1-3N1-2M0 or T2-3N0M0 (Stage II-III) per AJCC 8th edition
  • Adequate organ function as defined by blood counts and liver, kidney tests within specified limits
  • Signed informed consent and willingness to follow all study procedures
Not Eligible

You will not qualify if you...

  • Recurrent or distant metastatic nasopharyngeal carcinoma or other malignancy
  • Severe organ dysfunction or physical disorders preventing surgery, radiotherapy, or chemotherapy
  • Retropharyngeal lymph node diameter >1.5cm or extranodal invasion including carotid artery or muscle
  • Cervical lymph node diameter >3cm, located below lower margin of cricoid cartilage, or extranodal invasion including carotid artery, skin, muscle, mediastinal structures, prevertebral fascia, cervical spine, or extensive spread
  • Unable to cooperate with regular follow-up due to psychological, social, domestic, or geographic reasons
  • Pregnancy or lactation
  • Other conditions deemed exclusionary by the chief physician

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China, 519000

Actively Recruiting

Loading map...

Research Team

M

Ming-Yuan Chen, MD,PhD

CONTACT

Y

You-Ping Liu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here