Limited neck dissection versus full neck dissection - in limited nodal metastasis in mouth cancers - which is better

Addressing level V in N+ necks in oral cavity carcinomas - resolution of the debate - SECOND - SElective versus COmprehensive Neck Dissection in node positive neck.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/11/047490

Enrollment

200

Registered

2022-11-21

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx Health Condition 2: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

Intervention1: Neck dissection: Selective neck dissection ( level I - IV ) versus Modified neck dissection ( level I -V) in limited nodal metastasis till 3 years Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with age >=18 with histologically proven squamous cell carcinoma of the oral cavity with clinicoradiological evidence of node, that is cN+ , with no clinical or radiological evidence of extranodal extension( ENE) will be included in the study. 2. Patients with nodal staging N1, N2a and N2b will be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with previous history of radiation or surgery will not be included in the study. 2. Patients with nodes at level IV or level V will not be included in the study. 3. Patients with nodal involvement at multiple levels, that is - more than 2 will not be included in the study.

Design outcomes

Primary

Measure	Time frame
To assess the 2 year disease specific survival (DSS) and 2 years overall survival (OS) in patients undergoing selective neck dissection (level I- IV) versus patients undergoing comprehensive neck dissection ( level I â?? V) in clinicoradiologically N+ necks in oral cavity squamous cell carcinoma.Timepoint: To assess the 2 year disease specific survival (DSS) and 2 years overall survival (OS) in patients undergoing selective neck dissection (level I- IV) versus patients undergoing comprehensive neck dissection ( level I â?? V) in clinicoradiologically N+ necks in oral cavity squamous cell carcinoma.	—

Measure

Time frame

To assess the 2 year disease specific survival (DSS) and 2 years overall survival (OS) in patients undergoing selective neck dissection (level I- IV) versus patients undergoing comprehensive neck dissection ( level I â?? V) in clinicoradiologically N+ necks in oral cavity squamous cell carcinoma.Timepoint: To assess the 2 year disease specific survival (DSS) and 2 years overall survival (OS) in patients undergoing selective neck dissection (level I- IV) versus patients undergoing comprehensive neck dissection ( level I â?? V) in clinicoradiologically N+ necks in oral cavity squamous cell carcinoma.

—

Secondary

Measure	Time frame
To assess the involvement of level V lymph nodes in all the patients undergoing a comprehensive neck dissection in oral cavity carcinoma.Timepoint: Histopathology report after surgery - 15 days	—

Countries

India

Contacts

Public ContactDr Khyati Bhatia Grover

Max Superspeciality Hospital Patparganj and Vaisahli

khyati222@gmail.com8802081838

Outcome results

None listed

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