Oral Cavity Squamous Cell CarcinomaExtentN1NCT07717307
Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread
A study testing Selective Neck Dissection (Levels I-IV) and Modified Neck Dissection (Levels I-V) in people with Oral Cavity Squamous Cell Carcinoma, run by Kolhapur Cancer Centre - Cancer Centers of America at 1 site in India.
Trial summary
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Selective Neck Dissection (Levels I-IV) and Modified Neck Dissection (Levels I-V)
- 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
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 1 Aug 2026to 23 Apr 2031
- 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
- Histologically proven squamous cell carcinoma of oral cavity will be included
- Clinical stage T1-T4, N1, M0
- cN1 neck on clinical examination and imaging (CT/MRI)
- Single node which is FNAC proven without any other significant nodes.
- Patients with ASA grade II and I.
- Understands the protocol and able to give informed consent.
Who cannot join
- Recurrent cases
- Multiple significant nodes
- Nodes clinical/radiological with ENE
- Single metastatic node at level III/IV/V
- Single metastatic node with other suspicious nodes
- Patients with a history of head and neck radiation therapy treatment
- Previous history of any malignancy
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
Kolhāpur, Maharashtra, 416004
Maroti B Wadewale, MDS, FHNO, +918483851334, dr.marotiwadewale59@gmail.com
Yogesh Anap, MD, +919867155930, yogesh.anap1@gmail.com
About this study
Official title: Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking.
The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm.
Read more
The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities.
This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
Read the detailed description
Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.
Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.
The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.
The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving function and quality of life.
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Being tested
- Selective Neck Dissection (Levels I-IV), Modified Neck Dissection (Levels I-V)
- Keywords
- Oral Cavity Squamous Cell Carcinoma, Oral Cancer, Head and Neck Cancer, Neck Dissection, Modified Neck Dissection, Cervical Lymph Node Metastasis
- 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 will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
Modified Neck Dissection (Levels I-V)Procedure or surgery
Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1- Selective neck dissection level I to level IV | Experimental | Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings. Receives: Procedure: Selective Neck Dissection (Levels I-IV) |
| Arm 2- Modified Neck Dissection (Levels I-V) | Active comparator | Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings. Receives: Procedure: Modified Neck Dissection (Levels I-V) |
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 definitive surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Regional recurrence will be confirmed by clinical examination, imaging, and histopathological evaluation whenever feasible.
Measured: 3 years after surgery
Secondary outcomes (7)
Overall Survival (OS)
Overall survival is defined as the time from definitive surgery until death from any cause.
Measured: Up to 3 years after surgery
Disease-Free Survival (DFS)
Disease-free survival is defined as the time from definitive surgery to the first documented local, regional, or distant recurrence, or death from any cause.
Measured: Up to 3 years after surgery
Level-wise Cervical Lymph Node Metastasis
Distribution of histopathologically confirmed metastatic lymph nodes according to cervical nodal level.
Measured: At the time of surgery (histopathological examination)
Nodal Yield
Total number of lymph nodes retrieved during neck dissection and confirmed by histopathological examination.
Measured: At the time of surgery
Shoulder Function assesment
Shoulder function will be assessed using the Constant-Murley Score (0-100 points), with higher scores indicating better shoulder function.
Measured: Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
Postoperative Surgical Morbidity
Incidence of postoperative complications, including chyle leak, hematoma, wound infection, seroma, cranial nerve injury
Measured: Within 30 days after surgery
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 posted21 Jul 2026
- Study start1 Aug 2026
- Primary completion22 Apr 2031 (estimated)
- Study completion23 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies 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 randomized in a 1:1 ratio to one of two surgical treatment arms using a computer-generated stratified permuted block randomization sequence with variable block sizes. Stratification will be based on primary tumor subsite and clinical T stage to ensure balanced allocation. This is an open-label trial because blinding of surgeons and participants is not feasible due to the nature of the surgical interventions. However, postoperative functional and quality-of-life assessments will be performed by outcome assessors who are blinded to treatment allocation whenever feasible. All analyses will follow the intention-to-treat principle.
- Masking
- None (open label)
- Enrolment
- 80 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717307
- Sponsor's protocol ID
- ExteNTN1
- Acronym
- ExtentN1
- Status last verified
- Aug 2026
- First submitted
- 11 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
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.
PubMed 23996343Liang L, Zhang T, Kong Q, Liang J, Liao G. A meta-analysis on selective versus comprehensive neck dissection in oral squamous cell carcinoma patients with clinically node-positive neck. Oral Oncol. 2015 Dec;51(12):1076-81. doi: 10.1016/j.oraloncology.2015.10.005. Epub 2015 Oct 23.
PubMed 26500065Hashmi SS, Abbas A, Bukhari A, Saeed J, Shafqat A, Siddique AH, Buksh AR, Murtaza G. Selective Neck Dissection for Node-Positive Oral Cavity Squamous Cell Carcinoma: A Retrospective Cohort Study. Int Arch Otorhinolaryngol. 2022 Feb 22;26(4):e630-e635. doi: 10.1055/s-0041-1741437. eCollection 2022 Oct.
PubMed 36405475Shin YS, Koh YW, Kim SH, Choi EC. Selective neck dissection for clinically node-positive oral cavity squamous cell carcinoma. Yonsei Med J. 2013 Jan 1;54(1):139-44. doi: 10.3349/ymj.2013.54.1.139.
PubMed 23225810
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 of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07717307
- Acronym / sponsor ID
- ExtentN1 / ExteNTN1
- Conditions
- Oral Cavity Squamous Cell Carcinoma
- Keywords
- Oral Cavity Squamous Cell Carcinoma, Oral Cancer, Head and Neck Cancer, Neck Dissection, Modified Neck Dissection, Cervical Lymph Node Metastasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kolhapur Cancer Centre - Cancer Centers of AmericaUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 22 Apr 2031 (estimated)
- Study completion
- 23 Apr 2031 (estimated)
- First posted
- 21 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.
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking.
The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm.
The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities.
This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
Detailed description
Cervical lymph node metastasis is the most important prognostic factor in oral cavity squamous cell carcinoma (OCSCC). Surgical management of the neck is an integral component of treatment; however, the optimal extent of neck dissection for patients with clinically node-positive (cN1) disease remains uncertain. Although modified neck dissection (levels I-V with preservation of non-lymphatic structures) has traditionally been recommended for node-positive disease, several retrospective studies have suggested that carefully selected patients with limited nodal disease may achieve comparable regional control with a less extensive selective neck dissection. Nevertheless, these studies are subject to selection bias, and no adequately powered randomized controlled trial has directly compared these surgical approaches.
Dissection of lower cervical nodal levels may increase operative time and postoperative morbidity, including shoulder dysfunction, sensory deficits, chyle leak, and impairment in quality of life. Reducing the extent of neck dissection without compromising oncologic outcomes could improve postoperative functional recovery and patient-reported outcomes while maintaining regional disease control.
The ExteNT N1 Trial is designed to address this evidence gap by comparing selective neck dissection (levels I-IV) with modified neck dissection (levels I-V) in patients with resectable cN1 OCSCC. In addition to evaluating oncologic outcomes, the study incorporates validated functional and quality-of-life assessments to comprehensively evaluate the impact of the two surgical strategies. Participants will receive standard treatment for the primary tumor, and adjuvant therapy will be administered according to final histopathological findings and contemporary treatment guidelines.
The findings of this trial are expected to provide high-level evidence to guide the surgical management of the clinically N1 neck in OCSCC. If selective neck dissection demonstrates equivalent oncologic outcomes with lower morbidity, it may support a change in surgical practice by reducing unnecessary treatment while preserving 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 randomized in a 1:1 ratio to one of two surgical treatment arms using a computer-generated stratified permuted block randomization sequence with variable block sizes. Stratification will be based on primary tumor subsite and clinical T stage to ensure balanced allocation. This is an open-label trial because blinding of surgeons and participants is not feasible due to the nature of the surgical interventions. However, postoperative functional and quality-of-life assessments will be performed by outcome assessors who are blinded to treatment allocation whenever feasible. All analyses will follow the intention-to-treat principle.
| Arm | Type | Receives |
|---|---|---|
| Arm 1- Selective neck dissection level I to level IV | Experimental | Procedure: Selective Neck Dissection (Levels I-IV)Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings. |
| Arm 2- Modified Neck Dissection (Levels I-V) | Active comparator | Procedure: Modified Neck Dissection (Levels I-V)Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven squamous cell carcinoma of oral cavity will be included
- Clinical stage T1-T4, N1, M0
- cN1 neck on clinical examination and imaging (CT/MRI)
- Single node which is FNAC proven without any other significant nodes.
- Patients with ASA grade II and I.
Key exclusion criteria (7 listed)
- Recurrent cases
- Multiple significant nodes
- Nodes clinical/radiological with ENE
- Single metastatic node at level III/IV/V
- Single metastatic node with other suspicious nodes
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 will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, and IV on the ipsilateral side while preserving uninvolved non-lymphatic structures. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings. | Procedure or surgery | Arm 1- Selective neck dissection level I to level IV |
| Modified Neck Dissection (Levels I-V)Modified neck dissection will include removal of cervical lymph node levels Ia, Ib, IIa, IIb, III, IV, and V on the ipsilateral side while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. The primary oral cavity tumor will be resected according to oncologic principles with reconstruction as required. Contralateral neck management and adjuvant therapy will be provided according to institutional protocols and final histopathological findings. | Procedure or surgery | Arm 2- Modified Neck Dissection (Levels I-V) |
Primary outcome
Regional Recurrence-Free Survival (RRFS)
Time frame: 3 years after surgery
Regional recurrence-free survival is defined as the time from the date of definitive surgery to the first documented regional recurrence in the cervical lymph nodes or death from any cause, whichever occurs first. Regional recurrence will be confirmed by clinical examination, imaging, and histopathological evaluation whenever feasible.
7 secondary outcomes
Overall Survival (OS)
Time frame: Up to 3 years after surgery
Disease-Free Survival (DFS)
Time frame: Up to 3 years after surgery
Level-wise Cervical Lymph Node Metastasis
Time frame: At the time of surgery (histopathological examination)
Nodal Yield
Time frame: At the time of surgery
Shoulder Function assesment
Time frame: Preoperatively; 1 month; 3 months; 6 months, 1 and 2 year
Postoperative Surgical Morbidity
Time frame: Within 30 days after surgery
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 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 26500065Liang L, Zhang T, Kong Q, Liang J, Liao G. A meta-analysis on selective versus comprehensive neck dissection in oral squamous cell carcinoma patients with clinically node-positive neck. Oral Oncol. 2015 Dec;51(12):1076-81. doi: 10.1016/j.oraloncology.2015.10.005. Epub 2015 Oct 23.
- Results publication: PubMed 36405475Hashmi SS, Abbas A, Bukhari A, Saeed J, Shafqat A, Siddique AH, Buksh AR, Murtaza G. Selective Neck Dissection for Node-Positive Oral Cavity Squamous Cell Carcinoma: A Retrospective Cohort Study. Int Arch Otorhinolaryngol. 2022 Feb 22;26(4):e630-e635. doi: 10.1055/s-0041-1741437. eCollection 2022 Oct.
- Results publication: PubMed 23225810Shin YS, Koh YW, Kim SH, Choi EC. Selective neck dissection for clinically node-positive oral cavity squamous cell carcinoma. Yonsei Med J. 2013 Jan 1;54(1):139-44. doi: 10.3349/ymj.2013.54.1.139.
- 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.
Related trials for Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
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.
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 Modified Neck Dissection (Levels I-V) in people with Oral Cavity Squamous Cell Carcinoma, 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 6 inclusion and 7 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: 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 NCT07717307, which also lists 4 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.