Oral Squamous Cell Carcinoma (OSCC)ExtentN0NCT07726199
Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread
A study testing Selective Neck Dissection (Levels I-IV) and Intervention : Selective Neck Dissection (Levels I-III) in people with Oral Squamous Cell Carcinoma (OSCC), run by Kolhapur Cancer Centre - Cancer Centers of America at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma (OSCC)
- What is being tested?
- Selective Neck Dissection (Levels I-IV) and Intervention : Selective Neck Dissection (Levels I-III)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 1 siteIndia
- Study dates
- 22 Apr 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Kolhapur Cancer Centre- Cancer Centers of America
Kolhāpur, Maharashtra, 416234
Parag Watve, MS, FHNS, +918483851334, paragwatve@kolhapurcancercentre.com
Yogesh Anap, MD, +919867155930, yogesh.anap1@gmail.com
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Being tested
- Selective Neck Dissection (Levels I-IV), Intervention : Selective Neck Dissection (Levels I-III)
- Keywords
- Oral Squamous Cell Carcinoma, Oral Cancer, cN0, Selective Neck Dissection, Occult Nodal Metastasis, Regional Recurrence, Head and Neck Cancer, Randomized Controlled Trial
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Neck Dissection (Levels I-IV)Procedure or surgery
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.
Intervention : Selective Neck Dissection (Levels I-III)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III. | Active comparator | 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. Receives: Procedure: Intervention : Selective Neck Dissection (Levels I-III) |
| Arm 2- Selective neck dissection level I, II, III and IV | Experimental | 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. Receives: Procedure: Selective Neck Dissection (Levels I-IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence free survival (RRFS)
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.
Measured: From the date of surgery to 3 years after surgery
Secondary outcomes (7)
Overall Survival (OS)
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.
Measured: From the date of surgery to 3 years after surgery.
Disease-Free Survival (DFS)
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.
Measured: From the date of surgery to 3 years after surgery.
Occult Nodal Metastasis Rate
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.
Measured: Within 4 weeks after surgery (following final histopathological examination).
Patterns of Regional Nodal Failure
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.
Measured: From the date of surgery to 3 years after surgery.
Shoulder Function
Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
Measured: Baseline (preoperatively) and at 1 month, 3 months, 6 months, 12 months, and 24 months after surgery.
Neck Dissection Impairment
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.
Measured: assessed at 1 month, 3 months, 6 months, 12 months, and 24 months postoperatively.
Shoulder function assesment with Shoulder pain and disability index
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.
Measured: Preoperatively; 1 week; 1 month; 3 months; 6 months; 1 year; and 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start22 Apr 2026
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell Carcinoma (OSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 267 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolhapur Cancer Centre - Cancer Centers of America
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maroti Wadewale, Kolhapur Cancer Centre - Cancer Centers of America
- Investigators
- Maroti B Wadewale, MDS, FHNO, Principal investigator, Kolhapur Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726199
- Sponsor's protocol ID
- ExteNT N0 trial
- Acronym
- ExtentN0
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 18674952Taylor 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.
PubMed 11784253Cappiello 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.
PubMed 15689746Results 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.
PubMed 9874426Pantvaidya 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.
PubMed 23996343D'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.
PubMed 26027881Woolgar 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.
PubMed 16150633
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07726199
- Acronym / sponsor ID
- ExtentN0 / ExteNT N0 trial
- Conditions
- Oral Squamous Cell Carcinoma (OSCC)
- Keywords
- Oral Squamous Cell Carcinoma, Oral Cancer, cN0, Selective Neck Dissection, Occult Nodal Metastasis, Regional Recurrence, Head and Neck Cancer, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 267 participants (estimated)
- Lead sponsor
- Kolhapur Cancer Centre - Cancer Centers of AmericaUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III. | Active comparator | Procedure: Intervention : Selective Neck Dissection (Levels I-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. |
| Arm 2- Selective neck dissection level I, II, III and IV | Experimental | Procedure: Selective Neck Dissection (Levels I-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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Arm 2- Selective neck dissection level I, II, III and IV |
| 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. | Procedure or surgery | Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III. |
Primary outcome
Regional recurrence free survival (RRFS)
Time frame: 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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Results publication: PubMed 18674952Shah 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.
- Results publication: PubMed 11784253Taylor 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 publication: PubMed 15689746Cappiello 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.
- Results publication: PubMed 9874426Results 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.
- Results publication: PubMed 23996343Pantvaidya 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.
- Results publication: PubMed 26027881D'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.
- Results publication: PubMed 16150633Woolgar 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.
- Globocan dataLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maroti B Wadewale, MDS, FHNO principal investigator
Kolhapur Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Neck Dissection (Levels I-IV) and Intervention : Selective Neck Dissection (Levels I-III) in people with Oral Squamous Cell Carcinoma (OSCC), run by Kolhapur Cancer Centre - Cancer Centers of America at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maroti B Wadewale, MDS, FHNO (+918483851334, dr.marotiwadewale59@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence free survival (RRFS) (time frame: From the date of surgery to 3 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07726199, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.