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Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative

Study acronym: SECOND N0
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv7
  2. Start date changed from estimate of Mar 15, 2025 to Apr 16, 2025v6
  3. Start date: Nov 2024 to Mar 15, 2025 Study sites: 2 to 3v5 Show 1 more changeShow less
    • Study sites: 2 to 3
  4. Study sites: 1 to 2 Publications: 8 to 5v4 Show 1 more changeShow less
    • Publications: 8 to 5

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Not Yet Recruiting to Recruiting Start date: Apr 2023 to Nov 2024 · Site details revised · Publications: 7 to 8v3 Show 3 more changesShow less
    • Start date: Apr 2023 to Nov 2024
    • Site details revised
    • Publications: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: * Survival outcomes * Morbidity outcomes * Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END). The study will compare the outcomes in the two cohorts.
Trial Details
NCT Number NCT05774483
Lead Sponsor Tata Memorial Hospital
Collaborators: Tata Memorial Centre
Conditions Mouth Neoplasms, Oral Cancers, Oral Squamous Cell Carcinoma (OSCC), Oral Squamous Cell Carcinomas, Sentinel Lymph Node Biopsy, Sentinel Lymph Node Biopsy (SLNB), Sentinel Lymph Node
Enrollment 508 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov