A prospective, randomized, controlled, multicenter, non-inferiority study of selective zone VI neck dissection versus no dissection for glottic laryngeal cancer (cT3N0M0) requiring total laryngectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400086296

Enrollment

Unknown

Registered

2024-06-28

Start date

2024-07-01

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Laryngeal cancer

Interventions

Neck area VI observation group:Radical laryngopharyngectomy combined with cervical lymph node dissection at level II-IV

Neck area VI dissection group:Radical laryngopharyngectomy combined with neck II-IV and VI lymph node dissection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? The primary disease is T3N0M0 glottic laryngeal cancer (AJCC Laryngeal Cancer 8th Edition); ? Age 18 to 80 years old; ? No total laryngeal surgery before the start of the clinical trial; ? No neck lymph node dissection before the start of the clinical trial; ? Patients who can undergo surgery; ? Patients without second primary tumors and distant metastases; ? Generally good: KPS = 70; ? The patient has signed the informed consent form.

Exclusion criteria

Exclusion criteria: ? Patients without pathological results in our hospital; ? Patients with distant metastasis or unknown tumor stage; ? Patients with unknown cause of death or incomplete survival data; ? Patients who do not agree to sign the informed consent form; ? Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographical reasons; ? Patients who are receiving experimental treatment in other clinical studies at the same time (in the treatment period of clinical studies); ? Patients with severe uncontrollable infections or medical diseases; ? Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, who cannot tolerate surgical treatment; ? Factors that affect surgery or anesthesia, such as severe organ dysfunction, etc.; ? Patients who use immunosuppressants for a long time after organ transplantation; ? Patients with a history of other malignant tumors before enrollment.

Design outcomes

Primary

Measure	Time frame
5-year overall survival;	—

Secondary

Measure	Time frame
Locoregional recurrence-free time;Progression-free survival;Distant metastasis-free survival;Short-term efficacy indicators;	—

Countries

China

Contacts

Public ContactWenbin Lei

The First Affiliated Hospital of Sun Yat-Sen University

leiwb@mail.sysu.edu.cn+86 139 2211 3299

Outcome results

None listed

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