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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

Conditions

Surgery, Recurrent Nasopharyngeal Carcinoma

Being tested

Plasma radiofrequency ablation, Electrocautery block resection

Keywords

recurrent nasopharyngeal carcinoma, Plasma Radiofrequency Ablation, Electrocautery Block Resection

Medical subject headings

Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Plasma radiofrequency ablationProcedure or surgery

  Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are completely removed through the bilateral nasal cavity. Then investigators use plasma radiofrequency ablation at low temperature to ablate the tumor tissue and normal tissue of the margin along the upper and lower surgical margin until no obvious tumor remained under the naked eye.

• Electrocautery block resectionProcedure or surgery

  Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are continuously and completely removed through the bilateral nasal cavity. Then investigators separate the posterior part of the nasal cavity and the top wall of the nasopharynx along the bone of the nasopharyngeal fornix, cut the pharyngeal suture, and cut the two sides along the edge of the carina, and then merge along the anterior vertebral muscle surface to the midline incision. Along the the soft palate under the inferior margin, investigators horizontally cut the mucosa of the posterior wall of the nasopharynx, and completely frees the entire soft tissue of the posterior wall of the nasopharynx.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Progression-free survival

   Time from randomisation to the date of disease progression or death from any causes.

   whichever came first.

   Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted11 Jun 2020
2. Study start30 Jun 2020
3. Primary completionDec 2026 (estimated)
4. Study completionDec 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for SurgeryStudies of the same condition, open and under way.
• More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.