NCT03353467

Endoscopic Nasopharyngectomy for Newly Diagnosed Stage I Nasopharyngeal Carcinoma Patients

Recruiting now NA Last updated 3 June 2021

What this trial tests

NA trial testing Endoscopic surgery in Nasopharyngeal Carcinoma in 228 participants. Currently enrolling.

Timeline

1 October 2017

Primary endpoint
1 October 2025

1 October 2028

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	228
Start date	1 October 2017
Primary completion	1 October 2025
Estimated completion	1 October 2028
Sites	5 locations across China

Drugs / interventions tested

• Endoscopic surgery
• Intensity-modulated radiotherapy

Conditions studied

• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →
• Endoscopic Surgery — all drugs for Endoscopic Surgery →
• Primary Napharyngeal Carcinama — all drugs for Primary Napharyngeal Carcinama →
• Stage I Nasopharyngeal Cancer — all drugs for Stage I Nasopharyngeal Cancer →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 70, any sex, with Nasopharyngeal Carcinoma or Endoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Nasopharyngeal carcinoma (NPC) is most prevalent in eastern Asia, with the highest incidence reported among the Cantonese population from the province of Guangdong. Radiotherapy is the cornerstone of initial treatment due to the radiosensitive behavior of NPC and its deep-seated location. Although radiotherapy has achieved satisfactory results, it can also cause some severe adverse events. Currently, surgery is only applied to the treatment of recurrent NPC (rNPC) patients, mainly dominated by the conventional open surgery. However, the traditional surgery was accompanied by high rate of treatment-induced complications and low rate of block removal, which greatly limited the surgical application to the treatment of primary NPC.

With the continuous improvement in surgical techniques, especially the electronic endoscopic system to be used in the surgical treatment recently, endoscopic nasopharyngectomy can largely overcome these shortcomings of traditional surgery mentioned above.

In addition, the investigators retrospectively analyzed the survival outcomes of 9 patients with NPC (all T1N0M0 according to the UICC / AJCC seventh staging) treated with endoscopic nasopharyngectomy in our hospital, with 5-year rate of overall survival, loco-regional-free survival, distant metastasis-free survival of 100%. Therefore, the investigators considered endoscopic nasopharyngectomy for staged I NPC patients feasible.

This study will focus on the survival outcomes and quality of life of the staged I NPC patients treated with endoscopic nasopharyngectomy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in pathogenesis and precision medicine for nasopharyngeal carcinoma.
   Zhu QY, Zhao GX, Li Y, Talakatta G, et al · · 2021 · cited 41× · PMID 34766141 · DOI 10.1002/mco2.32
2. Minimally invasive surgery alone compared with intensity-modulated radiotherapy for primary stage I nasopharyngeal carcinoma.
   Liu YP, Lv X, Zou X, Hua YJ, et al · · 2019 · cited 33× · PMID 31730020 · DOI 10.1186/s40880-019-0415-3
3. [Comprehensive treatment strategies for head neck tumors].
   Huang Z, Wen W, Mao W. · · 2023 · cited 12× · PMID 37640991 · DOI 10.13201/j.issn.2096-7993.2023.09.001