Study comparing limited and extensive neck surgery in oral cancer patients with neck spread

ExteNT N1 Trial- Extent of Neck Treatment in clinically N1 oral cancer: A Randomized Controlled Trial - ExteNT N1 Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110558

Enrollment

Registered

2026-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: C049- Malignant neoplasm of floor of mouth, unspecified Health Condition 2: C039- Malignant neoplasm of gum, unspecified Health Condition 3: C029- Malignant neoplasm of tongue, unspecified Health Condition 4: O- Medical and Surgical

Interventions

Intervention1: Selective neck dissection level I to Level IV: The patients belongs to this group will undergo selective neck dissection from level I to IV which includes Removal of lymph node Levels I

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged over 21 years will be included Histologically proven squamous cell carcinoma of oral cavity will be included Clinical stage T1 to T4 N1 M0 cN1 neck on clinical examination and imaging like CT or MRI Single node which is FNAC proven without any other significant nodes No significant co-morbid conditions ASA grade II and I. Understands the protocol and able to give informed consent

Exclusion criteria

Exclusion criteria: Recurrent cases Multiple significant nodes Nodes clinical and radiological with ENE Single metastatic node at level III or IV or V Single metastatic node with other suspicious nodes Patients with history of head and neck radiation therapy treatment Previous history of any malignancy

Design outcomes

Primary

Measure	Time frame
To compare Regional recurrence free survival (RRFS) between SND I-V and MND I-V in patients with clinically N1 OSCC.Timepoint: at 1 month, 6 months, 1 year and 2 year	—

Secondary

Measure	Time frame
Overall Survival (OS) Timepoint: Overall Survival (OS), assessed at 12, 24, and 36 months post-surgery.;Disease-Free Survival (DFS) Timepoint: Disease-Free Survival assessed at 6 12 24 and 36 months post-surgery;Patterns of Regional Nodal FailureTimepoint: Patterns of regional nodal failure will be assessed at 6 12 24 and 36 months during follow-up.;Shoulder FunctionTimepoint: Shoulder function (Constant Murley score SPADI Arm Abduction Score)will be assessed preoperatively and at 1 week 1 month 3 months 6 months 12 months and 24 months postoperatively;Quality of LifeTimepoint: Quality of life (Neck Dissection Impairment Index), assessed at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.	—

Measure

Time frame

Overall Survival (OS) Timepoint: Overall Survival (OS), assessed at 12, 24, and 36 months post-surgery.;Disease-Free Survival (DFS) Timepoint: Disease-Free Survival assessed at 6 12 24 and 36 months post-surgery;Patterns of Regional Nodal FailureTimepoint: Patterns of regional nodal failure will be assessed at 6 12 24 and 36 months during follow-up.;Shoulder FunctionTimepoint: Shoulder function (Constant Murley score SPADI Arm Abduction Score)will be assessed preoperatively and at 1 week 1 month 3 months 6 months 12 months and 24 months postoperatively;Quality of LifeTimepoint: Quality of life (Neck Dissection Impairment Index), assessed at 1 week, 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.

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Countries

India

Contacts

Public ContactDr Parag Watve

Kolhapur Cancer Centre

paragwatve@kolhapurcancercentre.com08483851334

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026