Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread (ExtentN0)
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Maroti B Wadewale, MDS, FHNO
- Telefonnummer: +918483851334
- E-post: dr.marotiwadewale59@gmail.com
Studer Kontakt Backup
- Navn: Parag J Watve, MS, FHNS
- Telefonnummer: +919823109918
- E-post: paragwatve@kolhapurcancercentre.com
Studiesteder
-
-
Maharashtra
-
Kolhāpur, Maharashtra, India, 416234
- Rekruttering
- Kolhapur Cancer Centre- Cancer Centers of America
-
Ta kontakt med:
- Yogesh Anap, MD
- Telefonnummer: +919867155930
- E-post: yogesh.anap1@gmail.com
-
Hovedetterforsker:
- Maroti B Wadewale, MDS, FHNO
-
Ta kontakt med:
- Parag Watve, MS, FHNS
- Telefonnummer: +918483851334
- E-post: paragwatve@kolhapurcancercentre.com
-
Underetterforsker:
- Parag J Watve, MS, FHNS
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv 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.
|
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.
|
|
Eksperimentell: 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.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Regional recurrence free survival (RRFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Shoulder function assesment with Shoulder pain and disability index
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Maroti B Wadewale, MDS, FHNO, Kolhapur Cancer Centre
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Cappiello J, Piazza C, Giudice M, De Maria G, Nicolai P. Shoulder disability after different selective neck dissections (levels II-IV versus levels II-V): a comparative study. Laryngoscope. 2005 Feb;115(2):259-63. doi: 10.1097/01.mlg.0000154729.31281.da.
- Pantvaidya GH, Pal P, Vaidya AD, Pai PS, D'Cruz AK. Prospective study of 583 neck dissections in oral cancers: implications for clinical practice. Head Neck. 2014 Oct;36(10):1503-7. doi: 10.1002/hed.23494. Epub 2014 Jan 13.
- Shah JP, Gil Z. Current concepts in management of oral cancer--surgery. Oral Oncol. 2009 Apr-May;45(4-5):394-401. doi: 10.1016/j.oraloncology.2008.05.017. Epub 2008 Jul 31.
- Taylor RJ, Chepeha JC, Teknos TN, Bradford CR, Sharma PK, Terrell JE, Hogikyan ND, Wolf GT, Chepeha DB. Development and validation of the neck dissection impairment index: a quality of life measure. Arch Otolaryngol Head Neck Surg. 2002 Jan;128(1):44-9. doi: 10.1001/archotol.128.1.44.
- Results of a prospective trial on elective modified radical classical versus supraomohyoid neck dissection in the management of oral squamous carcinoma. Brazilian Head and Neck Cancer Study Group. Am J Surg. 1998 Nov;176(5):422-7. doi: 10.1016/s0002-9610(98)00230-x.
- D'Cruz AK, Vaish R, Kapre N, Dandekar M, Gupta S, Hawaldar R, Agarwal JP, Pantvaidya G, Chaukar D, Deshmukh A, Kane S, Arya S, Ghosh-Laskar S, Chaturvedi P, Pai P, Nair S, Nair D, Badwe R; Head and Neck Disease Management Group. Elective versus Therapeutic Neck Dissection in Node-Negative Oral Cancer. N Engl J Med. 2015 Aug 6;373(6):521-9. doi: 10.1056/NEJMoa1506007. Epub 2015 May 31.
- Woolgar JA. Histopathological prognosticators in oral and oropharyngeal squamous cell carcinoma. Oral Oncol. 2006 Mar;42(3):229-39. doi: 10.1016/j.oraloncology.2005.05.008. Epub 2005 Sep 16.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ExteNT N0 trial
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .