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Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread (ExtentN1)

1 augusti 2026 uppdaterad av: Maroti Wadewale, Kolhapur Cancer Centre - Cancer Centers of America

Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studera Kontakt Backup

Studieorter

  • Indien
    • Maharashtra
      • Kolhāpur, Maharashtra, Indien, 416004
        • Rekrytering
        • Kolhapur Cancer Centre
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Maroti B Wadewale, MDS, FHNO
        • Underutredare:
          • Parag Watve, MS, FHNS

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patients with a history of head and neck radiation therapy treatment
  • Previous history of any malignancy

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Arm 1- Selective neck dissection level I to level IV
Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
Procedur: Selective Neck Dissection (Levels I-IV)
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.
Aktiv komparator: Arm 2- Modified Neck Dissection (Levels I-V)
Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
Procedur: Modified Neck Dissection (Levels I-V)
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Regional Recurrence-Free Survival (RRFS)
Tidsram: 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.
3 years after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival (OS)
Tidsram: Up to 3 years after surgery
Overall survival is defined as the time from definitive surgery until death from any cause.
Up to 3 years after surgery
Disease-Free Survival (DFS)
Tidsram: 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.
Up to 3 years after surgery
Level-wise Cervical Lymph Node Metastasis
Tidsram: At the time of surgery (histopathological examination)
Distribution of histopathologically confirmed metastatic lymph nodes according to cervical nodal level.
At the time of surgery (histopathological examination)
Nodal Yield
Tidsram: At the time of surgery
Total number of lymph nodes retrieved during neck dissection and confirmed by histopathological examination.
At the time of surgery
Shoulder Function assesment
Tidsram: 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.
Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
Postoperative Surgical Morbidity
Tidsram: Within 30 days after surgery
Incidence of postoperative complications, including chyle leak, hematoma, wound infection, seroma, cranial nerve injury
Within 30 days after surgery
Shoulder function assesment with Shoulder pain and disability index
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Kolhapur Cancer Centre - Cancer Centers of America

Publikationer och användbara länkar

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Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 augusti 2026

Primärt slutförande (Beräknad)

22 april 2031

Avslutad studie (Beräknad)

23 april 2031

Studieregistreringsdatum

Först inskickad

11 juli 2026

Först inskickad som uppfyllde QC-kriterierna

16 juli 2026

Första postat (Faktisk)

21 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ExteNTN1

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

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