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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• 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 re
• 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.

Primary outcome measures

• Regional recurrence free survival (RRFS) [Time frame: From the date of surgery to 3 years after surgery]

Secondary outcome measures (7)

• Overall Survival (OS) [Time frame: From the date of surgery to 3 years after surgery.]
• Disease-Free Survival (DFS) [Time frame: From the date of surgery to 3 years after surgery.]
• Occult Nodal Metastasis Rate [Time frame: Within 4 weeks after surgery (following final histopathological examination).]
• Patterns of Regional Nodal Failure [Time frame: From the date of surgery to 3 years after surgery.]
• Shoulder Function [Time frame: Baseline (preoperatively) and at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.]
• Neck Dissection Impairment [Time frame: assessed at 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.]
• Shoulder function assesment with Shoulder pain and disability index [Time frame: Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

India · 1 center

• Kolhapur Cancer Centre- Cancer Centers of America — Kolhāpur

Publications

• 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. PMID 18674952
• 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. PMID 11784253
• 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. PMID 15689746
• 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. PMID 9874426
• 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. PMID 23996343
• 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. PMID 26027881
• 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. PMID 16150633

Identifiers

NCT: NCT07726199 · ExteNT N0 trial

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗