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Selective Neck Dissection versus Modified Neck Dissection Oral Squamous Cell Carcinoma.

A Prospective, Multicentric, Non inferiority Randomized Controlled Trial Comparing Outcomes of Selective Neck Dissection versus Modified Neck Dissection in Treatment-Naive, Node-Positive Oral Squamous Cell Carcinoma. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076784
Enrollment
432
Registered
2024-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Two Standard treatments are compared Selective Neck Dissection and Modified Neck Dissection.: Following informed consent and comprehensive pre-treatment evaluation, eligible patients wi

Sponsors

Dr Rakesh Katna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Treatment-naive patients with clinically and radiologically confirmed node-positive oral squamous cell carcinoma (T1-T4, N+). Nodal involvement is confirmed by CT, MRI, PET-CT along with ultrasound neck in all patients. Age between 18 and 70 years. ECOG performance status 0 or 1 or Karnofsky Performance Score (KPS) of 80 or higher. Subjects must have normal organ and marrow function. Written informed consent obtained in accordance with ICH-GCP guidelines and NDCT 2019 .

Exclusion criteria

Exclusion criteria: Patients with recurrent oral cancers. Bulky nodal disease more than 5 nodes or more than 6 cm in size. Involvement of level IV or V nodes. Any prior neoadjuvant chemotherapy or radiotherapy. Patients unwilling to comply with follow up or treatment protocols.

Design outcomes

Primary

MeasureTime frame
Disease-Free Survival (DFS)Timepoint: DFS is defined as the time from surgery until the first recurrence (local, regional, or distant) or death from any cause.

Secondary

MeasureTime frame
Overall Survival (OS)Timepoint: OS is defined as the time from surgery until death from any cause

Countries

India

Contacts

Public ContactZoya Peelay

Tieten Medicity Hospital

katna.rakesh@gmail.com9892705778

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 30, 2026