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

1 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

267

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Indië
    • Maharashtra
      • Kolhāpur, Maharashtra, Indië, 416234
        • Werving
        • Kolhapur Cancer Centre- Cancer Centers of America
        • Contact:
        • Hoofdonderzoeker:
          • Maroti B Wadewale, MDS, FHNO
        • Contact:
        • Onderonderzoeker:
          • Parag J Watve, MS, FHNS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: 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.
Experimenteel: 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.
Procedure: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Regional recurrence free survival (RRFS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Shoulder function assesment with Shoulder pain and disability index
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Kolhapur Cancer Centre - Cancer Centers of America

Onderzoekers

  • Hoofdonderzoeker: Maroti B Wadewale, MDS, FHNO, Kolhapur Cancer Centre

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

22 april 2026

Primaire voltooiing (Geschat)

1 september 2030

Studie voltooiing (Geschat)

1 september 2030

Studieregistratiedata

Eerst ingediend

9 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2026

Eerst geplaatst (Werkelijk)

24 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

1 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ExteNT N0 trial

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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