Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05352321

Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

Led by Sun Yat-sen University · Updated on 2022-07-01

264

Participants Needed

2

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.

CONDITIONS

Official Title

Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable 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 tumor classified as T1, T2, or T3 with clinical stage T1-3N1-3M0 or T2-3N0M0 (Stage II-IVA) per AJCC v8.
  • Surgically resectable cervical lymph nodes without invasion of major vessels or structures.
  • Surgically resectable retropharyngeal lymph nodes with intact capsule or measuring 1.5 cm or less with adequate mouth opening.
  • Adequate organ function including specific blood counts and liver, kidney, and coagulation parameters.
  • Signed informed consent agreeing to follow-up and study procedures.
Not Eligible

You will not qualify if you...

  • Recurrent or distant metastatic nasopharyngeal carcinoma or other malignancies.
  • Severe heart or lung disease with grade 3 or worse function.
  • Extensive tumor invasion beyond resectable areas such as skull base invasion or tumor close to internal carotid artery less than 0.75 cm.
  • Retropharyngeal lymph nodes involved or too close to nasopharyngeal tumor (less than 0.75 cm).
  • Inability to comply with follow-up due to psychological, social, or geographical reasons.
  • Pregnancy or breastfeeding.
  • Other conditions deemed unsuitable by the chief physician.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

M

Ming-yuan Chen, MD, PhD

CONTACT

R

Rui You, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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