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CTRI Number  CTRI/2024/11/076784 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 11/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Selective Neck Dissection versus Modified Neck Dissection Oral Squamous Cell Carcinoma. 
Scientific Title of Study   A Prospective, Multicentric, Non inferiority Randomized Controlled Trial Comparing Outcomes of Selective Neck Dissection versus Modified Neck Dissection in Treatment-Naive, Node-Positive Oral Squamous Cell Carcinoma. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Katna 
Designation  Consultant Surgical Oncology 
Affiliation  Tieten Medicity Hospital 
Address  Tieten Medicity Hospital, Kasarvadavali, Ghodbunder Road, Thane, Maharashtra, India.

Thane
MAHARASHTRA
400615
India 
Phone  9892705778  
Fax    
Email  katna.rakesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Katna 
Designation  Consultant Surgical Oncology 
Affiliation  Tieten Medicity Hospital 
Address  Tieten Medicity Hospital, Kasarvadavali, Ghodbunder Road, Thane, Maharashtra, India.

Thane
MAHARASHTRA
400615
India 
Phone  9892705778  
Fax    
Email  katna.rakesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Zoya Peelay 
Designation  Sr Clinical Research Manager 
Affiliation  Tieten Medicity Hospital 
Address  Tieten Medicity Hospital, Kasarvadavali, Ghodbunder Road, Thane, Maharashtra, India.

Thane
MAHARASHTRA
400615
India 
Phone  7028854123  
Fax    
Email  zoyapeelay@sunactcancer.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Rakesh Katna 
Address  Tieten Medicity,Kasarvadavali Thane West, Maharashtra 400615  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arjun Singh  Tieten Medicity Hospital  OPD floor,1st room, Dr Arjuns Cabin,Tieten Medicity Hospital, Kasarvadavali, Ghodbunder road, Thane (W.), Maharashtra 400615
Thane
MAHARASHTRA 		 9604897700

ms@tietenmedicity.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vedant Hospital Institutional Ethics Committee.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Two Standard treatments are compared Selective Neck Dissection and Modified Neck Dissection.  Following informed consent and comprehensive pre-treatment evaluation, eligible patients will be randomly assigned to one of two treatment groups: Arm 1 (SND Group): Participants will undergo primary tumor excision along with selective neck dissection. Adjuvant therapy (radiotherapy or chemoradiotherapy) will be administered based on adverse histopathological features such as extracapsular spread or positive surgical margins. Arm 2 (MND Group): Participants will undergo primary tumor excision along with modified neck dissection. Similar adjuvant therapy will be initiated based on comparable adverse features. Adjuvant radiotherapy will commence within six weeks post-surgery, adhering to a regimen of 60-64 Gy to high-risk regions and 54-57 Gy to low-risk areas. Chemotherapy will consist of cisplatin at 40 mg/m² weekly or 100 mg/m² every three weeks for six cycles. 
Intervention  Two Standard treatments are compared Selective Neck Dissection and Modified Neck Dissection.  Following informed consent and comprehensive pre-treatment evaluation, eligible patients will be randomly assigned to one of two treatment groups: Arm 1 (SND Group): Participants will undergo primary tumor excision along with selective neck dissection. Adjuvant therapy (radiotherapy or chemoradiotherapy) will be administered based on adverse histopathological features such as extracapsular spread or positive surgical margins. Arm 2 (MND Group): Participants will undergo primary tumor excision along with modified neck dissection. Similar adjuvant therapy will be initiated based on comparable adverse features. Adjuvant radiotherapy will commence within six weeks post-surgery, adhering to a regimen of 60-64 Gy to high-risk regions and 54-57 Gy to low-risk areas. Chemotherapy will consist of cisplatin at 40 mg/m² weekly or 100 mg/m² every three weeks for six cycles. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Treatment-naive patients with clinically and radiologically confirmed node-positive oral squamous cell carcinoma (T1-T4, N+).
Nodal involvement is confirmed by CT, MRI, PET-CT along with ultrasound neck in all patients.
Age between 18 and 70 years.
ECOG performance status 0 or 1 or Karnofsky Performance Score (KPS) of 80 or higher.
Subjects must have normal organ and marrow function.
Written informed consent obtained in accordance with ICH-GCP guidelines and NDCT 2019 . 
 
ExclusionCriteria 
Details  Patients with recurrent oral cancers.
Bulky nodal disease more than 5 nodes or more than 6 cm in size.
Involvement of level IV or V nodes.
Any prior neoadjuvant chemotherapy or radiotherapy.
Patients unwilling to comply with follow up or treatment protocols.
 
 
Method of Generating Random Sequence    
Method of Concealment   On-site computer system 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Disease-Free Survival (DFS)  DFS is defined as the time from surgery until the first recurrence (local, regional, or distant) or death from any cause.  
 
Secondary Outcome  
Outcome  TimePoints 
Overall Survival (OS)  OS is defined as the time from surgery until death from any cause 
 
Target Sample Size   Total Sample Size="432"
Sample Size from India="432" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Title :
A Prospective, Multicentric, Non inferiority Randomized Controlled Trial Comparing Outcomes of Selective Neck Dissection versus Modified Neck Dissection in Treatment-Naive, Node-Positive Oral Squamous Cell Carcinoma.

Rationale :
This study aims to bridge the gap in literature by conducting a multicentric, prospective, randomized controlled trial comparing the outcomes of SND versus MND in treatment-naive patients with node-positive OSCC. The primary endpoint will be disease-free survival (DFS), defined as the time from surgery to the first recurrence (local, regional, or distant) or death from any cause, with secondary endpoints including regional recurrence rates, overall survival (OS), treatment-related morbidity, and Quality of Life (QoL).

Primary Objective: To evaluate and compare disease-free survival (DFS) between patients undergoing selective neck dissection (SND) and those undergoing modified neck dissection (MND) for node-positive oral squamous cell carcinoma.

Secondary Objectives:

  1. To compare the regional recurrence rates associated with each surgical intervention.

  2. To assess overall survival (OS) between the two treatment arms.

  3. To evaluate treatment-related morbidity, including functional outcomes.

  4. To assess the impact on quality of life (QoL) using the EORTC QLQ-C30 and QLQ-H&N35 questionnaires.

Study Design :

This study is structured as a multicentric, prospective, randomized controlled trial (RCT) targeting treatment-naive patients with radiologically confirmed, node-positive oral squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to receive either selective neck dissection (SND) or modified neck dissection (MND).

Study Duration:

5 years (3 years of patient accrual and 2 years of follow-up).

Study setting :

The trial will be conducted at the following study sites:

  1. Tieten Medicity, Kasarvadavali, Thane

  2. Jaslok Hospital,Mumbai

  3. Bombay Hospital,Mumbai

  4. P.D. Hinduja Hospital, Khar,Mumbai

Sample Size:

A total of 432 patients, 216 patients in each arm, randomized in 1:1 manner will be required for the completion of the study.

Ethics and Regulatory Compliance:This study will be conducted in full compliance with;

  1. ICH-GCP guidelines, ensuring that the rights, safety, and well-being of the study participants are protected.
  2. NDCT 2019 regulations, ensuring that the study complies with all Indian regulatory requirements for clinical trials.
  3. Ethical approval is obtained from institutional ethics committees at all participating centers before patient recruitment. The trial will be registered with the Clinical Trials Registry of India (CTRI) as required by NDCT 2019 .
 
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