sentinel node biopsy versus limited neck dissection in node negative early oral cancer

Sentinel Node Biopsy versus limited Elective Neck Dissection in early Cancers of Oral cavity NoDe negative (SECOND N0): Non inferiority phase III trial - SECOND N0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052892

Enrollment

508

Registered

2023-05-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: C02- Malignant neoplasm of other and unspecified parts of tongue Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Limited elective neck dissection: All patients will undergo surgery for the primary disease. Subjects who are randomized to the limited END arm will undergo level Ia, Ib, IIa and III cl

Eligibility

Inclusion criteria

Inclusion criteria: 1) Age >18 years of age 2) Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa 3) T1 and T2 lesion as per AJCC TNM 8 th edition 4) Clinicoradiologically node negative 5) Amenable to per oral excision 6) Treatment naÃ¯ve 7) No other site of malignancy

Exclusion criteria

Exclusion criteria: 1) Previous surgery in the head and neck region, 2) Upper alveolar or palatal lesions 3) Large heterogeneous leukoplakia or other premalignant lesions 4) Previous malignancy in the head and neck region 5) Patients requiring the free flap reconstruction

Design outcomes

Primary

Measure	Time frame
1) Overall survival Timepoint: 1) Overall survival 3 years	—

Secondary

Measure	Time frame
1)Shoulder morbidity (key secondary end point) longitudinally up to 2 years 2) Disease free survival 3) Neck nodal recurrence free survival 4) Other side effects (chyle leak, hematoma, lymphoedema) 5) Longitudinal Quality of life up to 2 year 6) Cost effective analysisTimepoint: 1) At baseline before surgery, at 3,6,12 and 24 months after treatment 2) 3 years 3) 3 years 4) intraoperative/ lymphedema at 3,6,12,24 months after treatment 5) Baseline before surgery, 3,6,12,24 months after treatment 6)3 years	—

Measure

Time frame

1)Shoulder morbidity (key secondary end point) longitudinally up to 2 years 2) Disease free survival 3) Neck nodal recurrence free survival 4) Other side effects (chyle leak, hematoma, lymphoedema) 5) Longitudinal Quality of life up to 2 year 6) Cost effective analysisTimepoint: 1) At baseline before surgery, at 3,6,12 and 24 months after treatment 2) 3 years 3) 3 years 4) intraoperative/ lymphedema at 3,6,12,24 months after treatment 5) Baseline before surgery, 3,6,12,24 months after treatment 6)3 years

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Countries

India

Contacts

Public ContactDr Richa Vaish MS MCh

Tata Memorial Hospital

drvaishricha@gmail.com

Outcome results

None listed

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