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Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread (ExtentN0)

1 de agosto de 2026 actualizado por: Maroti Wadewale, Kolhapur Cancer Centre - Cancer Centers of America

ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial

The goal of this clinical trial is to learn whether selective neck dissection involving lymph node levels I-III is as effective as selective neck dissection involving levels I-IV in treating adults with clinically node-negative (cN0) oral squamous cell carcinoma undergoing curative surgery. It will also evaluate whether extending the neck dissection to level IV affects cancer control, surgical complications, shoulder function, and quality of life. The main questions it aims to answer are:

  • Does selective neck dissection of levels I-III provide regional recurrence-free survival comparable to selective neck dissection of levels I-IV?
  • Does extending the neck dissection to level IV improve overall survival, disease-free survival, or reduce regional recurrence?
  • Does selective neck dissection of levels I-III result in less postoperative morbidity, better shoulder function, and improved quality of life compared with selective neck dissection of levels I-IV?

Researchers will compare patients undergoing selective neck dissection of levels I-III with those undergoing selective neck dissection of levels I-IV to determine whether routine removal of level IV lymph nodes provides additional oncological benefit while maintaining acceptable functional outcomes.

Participants will:

  • Undergo surgery for oral squamous cell carcinoma with random assignment to selective neck dissection of either levels I-III or levels I-IV.
  • Receive standard postoperative treatment, including radiotherapy or chemoradiotherapy when indicated according to the final pathology report.
  • Attend scheduled follow-up visits for clinical examinations and surveillance for cancer recurrence.
  • Undergo assessments of shoulder function, sensory function, postoperative complications, and quality of life using validated questionnaires at predefined follow-up intervals.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Oral squamous cell carcinoma (OSCC) is one of the most common malignancies of the head and neck, with cervical lymph node metastasis being the most important prognostic factor affecting survival. In patients with clinically node-negative (cN0) neck disease, elective selective neck dissection is the standard of care because of the substantial risk of occult cervical metastasis. However, the optimal inferior extent of elective neck dissection remains controversial.

Selective neck dissection involving levels I-III is widely accepted for early-stage oral cavity cancer, while some surgeons routinely extend the dissection to level IV based on concerns regarding skip metastasis and the potential for improved regional disease control. Extending the dissection may increase operative time and postoperative morbidity, including shoulder dysfunction and sensory impairment, without providing additional oncological benefit. High-quality prospective evidence comparing these two approaches is limited.

The EXTENT N0 Trial is a prospective, parallel-group, randomized controlled trial designed to compare selective neck dissection of levels I-III with selective neck dissection of levels I-IV in adults with clinically node-negative oral squamous cell carcinoma undergoing primary curative surgery. Eligible participants will be randomly assigned in a 1:1 ratio to one of the two surgical approaches. Tumor resection, reconstruction, perioperative care, and adjuvant treatment will be provided according to institutional standards and multidisciplinary tumor board recommendations.

Participants will undergo regular postoperative follow-up with clinical examination and appropriate imaging according to the study schedule. Functional outcomes, postoperative complications, and quality of life will be assessed using validated instruments at predefined time points. The study aims to determine whether limiting elective neck dissection to levels I-III provides regional disease control comparable to levels I-IV while reducing treatment-related morbidity and preserving postoperative function and quality of life.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

267

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • India
    • Maharashtra
      • Kolhāpur, Maharashtra, India, 416234
        • Reclutamiento
        • Kolhapur Cancer Centre- Cancer Centers of America
        • Contacto:
        • Investigador principal:
          • Maroti B Wadewale, MDS, FHNO
        • Contacto:
        • Sub-Investigador:
          • Parag J Watve, MS, FHNS

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Patients aged over 21 years will be included.
  • Histologically proven squamous cell carcinoma of oral cavity will be included
  • Clinical stage T1-T4, N0, M0
  • cN0 neck on clinical examination and imaging (CT/MRI)
  • American Society of Anesthesiologists (ASA) Physical Status I or II
  • Understands the protocol
  • and can give informed consent.

Exclusion Criteria:

  • Recurrent cases
  • FNAC proven Positive cervical nodes
  • Patients with history of head and neck radiation therapy treatment
  • Previous neck surgery or radiotherapy
  • Previous history of any cancer

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III.
The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa and III. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.
Procedimiento: Intervention : Selective Neck Dissection (Levels I-III)
Selective neck dissection (Levels I-III) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, and III during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.
Experimental: Arm 2- Selective neck dissection level I, II, III and IV
The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa, III and IV. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.
Procedimiento: Selective Neck Dissection (Levels I-IV)
Selective Neck Dissection (Levels I-IV)- Selective neck dissection (Levels I-IV) involves surgical removal of ipsilateral cervical lymphatic tissue from neck levels I, II, III, and IV during primary resection of oral squamous cell carcinoma in patients with a clinically node-negative (cN0) neck. The procedure is performed according to standard oncological principles with preservation of the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle unless their sacrifice is required because of direct tumor involvement.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Regional recurrence free survival (RRFS)
Periodo de tiempo: From the date of surgery to 3 years after surgery
Regional recurrence-free survival is defined as the time from the date of surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last disease assessment.
From the date of surgery to 3 years after surgery

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Shoulder function assesment with Shoulder pain and disability index
Periodo de tiempo: 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.
Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
Overall Survival (OS)
Periodo de tiempo: From the date of surgery to 3 years after surgery.
Overall survival is defined as the time from the date of surgery to death from any cause. Participants who are alive at the time of the last follow-up will be censored on that date.
From the date of surgery to 3 years after surgery.
Disease-Free Survival (DFS)
Periodo de tiempo: From the date of surgery to 3 years after surgery.
Disease-free survival is defined as the time from the date of surgery to the first documented recurrence of disease (local, regional, or distant), the occurrence of a second primary malignancy, or death from any cause, whichever occurs first. Participants without an event will be censored at the date of the last disease assessment.
From the date of surgery to 3 years after surgery.
Occult Nodal Metastasis Rate
Periodo de tiempo: Within 4 weeks after surgery (following final histopathological examination).
Occult nodal metastasis rate is defined as the proportion of participants with histopathologically confirmed cervical lymph node metastasis identified on final pathological examination despite a clinically node-negative (cN0) neck before surgery.
Within 4 weeks after surgery (following final histopathological examination).
Patterns of Regional Nodal Failure
Periodo de tiempo: From the date of surgery to 3 years after surgery.
Patterns of regional nodal failure will be assessed by documenting the anatomical neck level(s), laterality, and timing of regional lymph node recurrence confirmed by clinical examination, imaging, or histopathological evaluation, and comparing their distribution between the two treatment groups.
From the date of surgery to 3 years after surgery.
Shoulder Function
Periodo de tiempo: Baseline (preoperatively) and at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.
Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
Baseline (preoperatively) and at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.
Neck Dissection Impairment
Periodo de tiempo: assessed at 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.
Neck dissection-related quality of life will be assessed using the Neck Dissection Impairment Index (NDII), a validated patient-reported outcome measure evaluating the impact of neck dissection on physical function, symptoms, and overall quality of life. The NDII is scored from 0 to 100, with higher scores indicating better neck-related quality of life and lower scores indicating greater impairment. Outcomes will be compared between the two treatment groups.
assessed at 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Kolhapur Cancer Centre - Cancer Centers of America

Investigadores

  • Investigador principal: Maroti B Wadewale, MDS, FHNO, Kolhapur Cancer Centre

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de abril de 2026

Finalización primaria (Estimado)

1 de septiembre de 2030

Finalización del estudio (Estimado)

1 de septiembre de 2030

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2026

Publicado por primera vez (Actual)

24 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

1 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ExteNT N0 trial

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No individual participant data (IPD) will be shared with other researchers. The study investigators do not have a plan to make de-identified participant-level data publicly available.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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