Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID04425265

A Randomized Controlled Trial of Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma

Led by Sun Yat-sen University · Updated on 2026-05-08

500

Participants Needed

3

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating plasma radiofrequency ablation at low temperature compared to electrocautery block resection at high frequency for patients with localized recurrent nasopharyngeal carcinoma. This randomized controlled trial aims to determine whether the low-temperature plasma radiofrequency technique leads to better survival outcomes. The study is sponsored by Sun Yat-sen University and focuses on a surgical approach to treat this specific type of cancer recurrence. Participants will be randomly assigned to one of two treatment groups. One group will receive plasma radiofrequency ablation under nasal endoscope guidance, where the tumor and surrounding tissue are carefully removed and ablated at low temperature until no visible tumor remains. The other group will undergo electrocautery block resection, involving a detailed surgical removal of the tumor and surrounding tissues through the nasal cavity. Both procedures are performed via the nasal passage under endoscopic view. Throughout the study, participants will be monitored for progression-free survival over two years, which is the primary outcome measure. Additional assessments include overall survival, relapse-free survival, distant metastasis-free survival, and complications related to surgery within one year. Quality of life will be evaluated using standardized questionnaires at one year. The total duration of follow-up will extend to two years to assess these outcomes and monitor participant well-being after surgery.

CONDITIONS

Brief Title

Plasma Radiofrequency Ablation at Low Temperature Versus Electrocautery Block Resection at High Frequency for Localized Recurrent Nasopharyngeal Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 6 months disease-free interval after initial radiotherapy
  • Diagnosed with undifferentiated or differentiated, nonkeratinizing nasopharyngeal carcinoma
  • Resectable recurrent nasopharyngeal carcinoma (rT1-3N0-3M0) confined to nasopharyngeal mucosa or nearby areas, more than 0.5 cm from internal carotid artery
  • Cervical lymph node lesions not infiltrating cervical spine, brachial plexus, cervical muscles, or internal carotid artery
  • Age between 18 and 70 years
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Karnofsky score less than or equal to 70
  • Presence of other malignant tumors
  • Serious mental disease
  • Uncontrolled significant heart disease or pulmonary dysfunction
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

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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 - Single treatment session

Participants receive either plasma radiofrequency ablation at low temperature or electrocautery block resection at high frequency to remove localized recurrent nasopharyngeal carcinoma.

1 treatment visit (in-person)

Follow-up

Duration - Up to 2 years

Participants are monitored for surgery-related complications and survival outcomes including progression-free survival and quality of life for up to 2 years after treatment.

Periodic follow-up visits over 2 years

Trial Site Locations

Total: 3 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

2

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China, 519000

Actively Recruiting

3

The Nanchang Affiliated Hospital, Sun Yat-Sen University (Nanchang First Hospital)

Nanchang, Jiangxi, China

Actively Recruiting

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Research Team

M

Ming-Yuan Chen, MD, PhD

Y

You-Ping Liu, MD, PhD

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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