NCT07717307Recruiting
Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread
Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking. The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm. The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities. This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 22 Apr 2031
- Lead sponsor
- Kolhapur Cancer Centre - Cancer Centers of America
- Diseases
- Head and neck cancer
- NCT number
- NCT07717307
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Aug 2026 to the primary completion date, 22 Apr 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of any malignancy
Other illness
- Patients with a history of head and neck radiation therapy treatment
Other
- Recurrent cases
- Multiple significant nodes
- Nodes clinical/radiological with ENE
- Single metastatic node at level III/IV/V
- Single metastatic node with other suspicious nodes
Who the study is looking for
- Histologically proven squamous cell carcinoma of oral cavity will be included
- Clinical stage T1-T4, N1, M0
- cN1 neck on clinical examination and imaging (CT/MRI)
- Single node which is FNAC proven without any other significant nodes.
- Patients with ASA grade II and I.
- Understands the protocol and able to give informed consent.
Age in the registry: 21 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kolhapur Cancer Centre Coordinator of this site? Confirm its status | Kolhāpur | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.