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Study of selective neck dissection navigated by sentinel node biopsy

Study of selective neck dissection navigated by sentinel node biopsy for T3-4aN0 advanced oral cancers (multiinstitutional randomized control study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1070240032
Enrollment
187
Registered
2024-07-14
Start date
2024-07-14
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

T3-4N0,Oral Cancer oral neoplasm

Interventions

Control group: Selective Neck Dissection Experimental group: SN-assisted selective neck dissection

Sponsors

Hirakawa Hitoshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with T3-4 oral squamous cell carcinoma without lymph node metastasis 2) Patients with no previous treatment for head and neck cancer 3) Patients who are at least 18 years old at the time of consent 4) Patients with written consent from the patient.

Exclusion criteria

Exclusion criteria: 1) Cases with PORT indication (extracapsular invasion, multiple cervical metastases) 2) Cases previously treated with cervical radiation 3) Pregnant or suspected pregnant 4) Cases with serious complications that do not tolerate radical surgery in the judgment of the attending physician 5) Cases deemed inappropriate for this study by the treating physician for other reasons

Design outcomes

Primary

MeasureTime frame
3-year neck recurrence-free survival rate

Secondary

MeasureTime frame
3-year crude survival rate, 3-year recurrence-free survival rate, postoperative dysfunction of neck dissection, SN false negative rate

Contacts

Public ContactShinya Agena

University of the Ryukyus

harugen3@yahoo.co.jp+81-98-895-1183

Outcome results

None listed

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