Study comparing different neck treatment approaches in patients with oral cancer without visible neck spread

ExteNT N0 Trial- Extent of Neck Treatment in clinically N0 oral cancer: A Randomized Controlled Trial - ExteNT N0 Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110147

Enrollment

267

Registered

2026-05-06

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: C040- Malignant neoplasm of anterior floor of mouth Health Condition 2: C021- Malignant neoplasm of border of tongue Health Condition 3: C039- Malignant neoplasm of gum, unspecified Health Condition 4: C009- Malignant neoplasm of lip, unspecified Health Condition 5: C069- Malignant neoplasm of mouth, unspecified Health Condition 6: C029- Malignant neoplasm of tongue, unspecified Health Condition 7: 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 N0 M0 cN0 neck on clinical examination and imaging like CT or MRI No significant co-morbid conditions ASA grade II and I Understands the protocol and is able to give informed consent

Exclusion criteria

Exclusion criteria: Recurrent cases FNAC proven Positive cervical nodes Suspicious nodes Patients with a history of head and neck radiation therapy treatment Previous neck surgery or radiotherapy

Design outcomes

Primary

Measure	Time frame
To compare Regional recurrence free survival (RRFS) between SND I-III and SND I-IV in patients with clinically N0 OSCC.Timepoint: Regional Recurrence-Free Survival (RRFS), assessed at 6 months, 12 months, 24 months, and 36 months following surgery, with the primary endpoint at 36 months.	—

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 (DFS), assessed at 6, 12, 24, and 36 months post-surgery.;Occult Nodal Metastasis RateTimepoint: Occult nodal metastasis rate, assessed on final histopathological examination within 4 weeks after surgery.;Patterns of Regional Nodal FailureTimepoint: Patterns of regional nodal failure, assessed at 6, 12, 24, and 36 months during follow-up.;Shoulder FunctionTimepoint: Shoulder function (Constant Murley score, SPADI, Arm Abduction Score), 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 (DFS), assessed at 6, 12, 24, and 36 months post-surgery.;Occult Nodal Metastasis RateTimepoint: Occult nodal metastasis rate, assessed on final histopathological examination within 4 weeks after surgery.;Patterns of Regional Nodal FailureTimepoint: Patterns of regional nodal failure, assessed at 6, 12, 24, and 36 months during follow-up.;Shoulder FunctionTimepoint: Shoulder function (Constant Murley score, SPADI, Arm Abduction Score), 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 ContactParag Watve

Kolhapur Cancer Centre Cancer Centres Of America Kolhapur

paragwatve@kolhapurcancercentre.com09823109918

Outcome results

None listed

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