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

1 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

267

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Indie
    • Maharashtra
      • Kolhāpur, Maharashtra, Indie, 416234
        • Rekrutacyjny
        • Kolhapur Cancer Centre- Cancer Centers of America
        • Kontakt:
        • Główny śledczy:
          • Maroti B Wadewale, MDS, FHNO
        • Kontakt:
        • Pod-śledczy:
          • Parag J Watve, MS, FHNS

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: 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.
Procedura: 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.
Eksperymentalny: 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.
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Regional recurrence free survival (RRFS)
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Shoulder function assesment with Shoulder pain and disability index
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Kolhapur Cancer Centre - Cancer Centers of America

Śledczy

  • Główny śledczy: Maroti B Wadewale, MDS, FHNO, Kolhapur Cancer Centre

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

22 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 września 2030

Ukończenie studiów (Szacowany)

1 września 2030

Daty rejestracji na studia

Pierwszy przesłany

9 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 lipca 2026

Pierwszy wysłany (Rzeczywisty)

24 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ExteNT N0 trial

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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