Oral Squamous Cell Carcinoma (OSCC)
Conditions
Keywords
Oral Squamous Cell Carcinoma, Oral Cancer, cN0, Selective Neck Dissection, Occult Nodal Metastasis, Regional Recurrence, Head and Neck Cancer, Randomized Controlled Trial
Brief summary
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
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.
PROCEDUREIntervention : 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.
Sponsors
Kolhapur Cancer Centre - Cancer Centers of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. One group will undergo selective neck dissection involving cervical lymph node levels I-III, while the other group will undergo selective neck dissection involving levels I-IV as part of primary surgical treatment for clinically node-negative oral squamous cell carcinoma. Participants will remain in their assigned intervention group throughout the study, and outcomes will be compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence free survival (RRFS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Disease-Free Survival (DFS) | 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. |
| Occult Nodal Metastasis Rate | 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. |
| Patterns of Regional Nodal Failure | 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. |
| Shoulder Function | 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. |
| Neck Dissection Impairment | 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. |
| Shoulder function assesment with Shoulder pain and disability index | 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. |
Countries
India
Contacts
CONTACTMaroti B Wadewale, MDS, FHNO
CONTACTParag J Watve, MS, FHNS
PRINCIPAL_INVESTIGATORMaroti B Wadewale, MDS, FHNO
Kolhapur Cancer Centre
Outcome results
None listed