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A prospective, randomized, controlled, multicenter clinical study of oral robotic endoscopic surgery versus transnasal endoscopic surgery for locally recurrent nasopharyngeal carcinoma

A prospective, randomized, controlled, multicenter clinical study of oral robotic endoscopic surgery versus transnasal endoscopic surgery for locally recurrent nasopharyngeal carcinoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068990
Enrollment
Unknown
Registered
2023-03-03
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal carcinoma

Interventions

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The nasopharyngeal lesions were histopathologically diagnosed as undifferentiated non-keratoma (poorly differentiated squamous cell carcinoma); 2. Lesions located in the nasopharyngeal cavity (rT1), nostril or nasal septum (rT2a), superficial parapharyngeal space (rT2b), or the bottom wall of the sphenoid sinus (rT3) were defined as operatively resectable lesions according to the eighth edition of the AJCC; 3. At least 1 year from the end of radiotherapy; 4. Karnofsky scale (KPS) >=70; 5. Aged 18-70 years, no gender limit; 6. Willing to undergo surgery, able to provide informed consent and participate in regular follow-up; 7. No systemic treatment, such as chemotherapy, immunotherapy, etc.

Exclusion criteria

Exclusion criteria: 1. The recurrent disease has received salvage treatment; 2. Distant metastasis; 3. Extensive recurrent primary tumors beyond the resectable area, such as extensive invasion of the skull base or a distance of less than 0.5 cm from the tumor margin to the internal carotid artery; 4. Recurrence of unresectable lymph nodes, such as invasion of carotid sheath; 5. Initial grade 3 or worse; 6. Life-threatening diseases of liver, kidney, heart and other organs, abnormal coagulation function or bleeding tendency; 7. Neurological or psychiatric diseases; 8. Unwilling to sign informed consent or participate in this study; 9. Patients with poor compliance; 10. Patients with restricted mouth opening; 11. Pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
3-year local recurrence free survival rate;The volume increase rate of affected nasal cavity 6 months after operation;

Secondary

MeasureTime frame
3-year overall survival rate;3-year local recurrence free survival;3-year progression free survival;Surgical margin;Operation time;Epithelialization time of operative cavity;Quality of life;Incidence of complications;

Countries

China

Contacts

Public ContactHuang Xiaoming

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

hxming@mail.sysu.edu.cn+86 136 0280 8820

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026