NCT Number: NCT07717307
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.
Interested in participating?
Request Info21 year–75 year
All sexes
Interventional
Not applicable
Kolhāpur, Maharashtra, 416004, India
Location status: Recruiting
Maroti B Wadewale, MDS, FHNO
CONTACT
Maroti B Wadewale, MDS, FHNO
PRINCIPAL_INVESTIGATOR
Parag Watve, MS, FHNS
SUB_INVESTIGATOR
Yogesh Anap, MD
CONTACT
Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.
Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.
The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.
The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving function and quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Selective neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
Time frame: 3 years after surgery
Regional recurrence-free survival is defined as the time from the date of definitive surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Regional recurrence will be confirmed by clinical examination, imaging, and histopathological evaluation whenever feasible.
Time frame: Up to 3 years after surgery
Overall survival is defined as the time from definitive surgery until death from any cause.
Time frame: Up to 3 years after surgery
Disease-free survival is defined as the time from definitive surgery to the first documented local, regional, or distant recurrence, or death from any cause.
Time frame: At the time of surgery (histopathological examination)
Distribution of histopathologically confirmed metastatic lymph nodes according to cervical nodal level.
Time frame: At the time of surgery
Total number of lymph nodes retrieved during neck dissection and confirmed by histopathological examination.
Time frame: Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
Time frame: Within 30 days after surgery
Incidence of postoperative complications, including chyle leak, hematoma, wound infection, seroma, cranial nerve injury
Time frame: Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
Shoulder pain and disability will be assessed using theShoulder pain and disability index questionnaire. Scores range from 0 to 100, with higher scores indicating greater pain and disability.
Contact information is provided by the study sponsor or research team.
Maroti B Wadewale, MDS, FHNO
CONTACT
Parag J Watve, MS, FHNS
CONTACT
Kolhapur Cancer Centre - Cancer Centers of America
Other
Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
Acronym: ExtentN1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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