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CTRI Number  CTRI/2025/11/097102 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluating oral reactions to radiotherapy in Head and Neck Cancer Patients undergoing chemotherapy and radiotherapy 
Scientific Title of Study   Evaluation of Severe Oral Mucositis in Locally Advanced Unresectable Head and Neck Squamous Cell Carcinoma (HNSCC) Patients Treated by Chemoradiotherapy (CTRT) Using Volumetric Modulated Arc Therapy (VMAT) with Simultaneous Integrated Boost (SIB) A Single Institution Prospective Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashutosh Mukherji 
Designation  Professor and Head of Department  
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital 
Address  Office of Head of Department Dept of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, Naria Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9489146747  
Fax    
Email  drashutoshm@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyajeet Das 
Designation  Junior Resident  
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital 
Address  Office of Head of Department, Dept of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, Naria Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9689604241  
Fax    
Email  satyajeetdas98@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gaurav Arya 
Designation  Research Fellow 
Affiliation  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital 
Address  Office of Head of Department, Dept of Radiation Oncology, Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital, Sundar Bagiya, Naria Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9031340291  
Fax    
Email  aryagaurav204@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahamana Pandit Madan Mohan Malaviya Cancer Centre and Homi Bhabha Cancer Hospital  
Address  Sundar Bagiya, Near Naria Gate, BHU Campus, Varanasi, Uttar Pradesh India 221005.  
Type of Sponsor  Research institution and hospital 
 
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 Satyajeet Das  Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMCC)  Office of Head of Department, Department of Radiation Oncology, MPMMCC, Varanasi, Uttar Pradesh 221005 India Varanasi UTTAR PRADESH 221005 India Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH 
9689604241

satyajeetdas98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C05||Malignant neoplasm of palate, (3) ICD-10 Condition: C09||Malignant neoplasm of tonsil, (4) ICD-10 Condition: C10||Malignant neoplasm of oropharynx, (5) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (6) ICD-10 Condition: C13||Malignant neoplasm of hypopharynx, (7) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Histologically proven HNSCC (Except Oral cavity)
2. Age - 18 to 70 years
3. Both sexes
4. ECOG Score 2 or less
5. Non-metastatic disease (T1-T4a, N0-3b).
6. Patients planned for radical treatment with chemo-radiation with dose of RT 66Gy in 30 fractions
7. Patient being treated using VMAT-SIB technique with concurrent cisplatin.
8. Willingness to sign informed consent form.
 
 
ExclusionCriteria 
Details  1. Any histopathology other than SCC
2. Previous radiotherapy to the head and neck region
3. Synchronous or metachronous malignancy
4. Pregnant or lactating women
5. Evidence of distant metastasis (any T, any N, M1).
6. Recurrent or residual disease
7. Oral cavity SCC patients
8. Previously operated patient in HN region.
9. Any other concurrent chemotherapy other than cisplatin
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate severe oral mucositis RTOG grade less than and equal to grade 3 in unresectable HNSCC treated with VMAT SIB along with concurrent cisplatin using RTOG Acute Morbidity Criteria Objective criteria and Mouth and Throat soreness score MTS and QLQ C30 HN questionnaires subjective patient reported criteria and their correlation.   Patients will be assessed at least once weekly during radiation. The first post treatment visit will be 1 weeks after completion of radiotherapy. Subsequent visits will be 1 month and 3 month post RT. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate other acute toxicities like skin reaction, dysphagia, odynophagia.
• To assess the need of
– Feeding tube placement
– Hospitalization
– Opioid use
– Significant weight loss (> 5 kg)
• To assess the correlation between various host and tumour related factors with treatment
response and outcome. 
Patients will be assessed at least once weekly during radiation. The first post treatment visit will be 1 weeks after completion of radiotherapy. Subsequent visits will be 1 month and 3 month post RT. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   N/A 
Date of First Enrollment (India)   21/11/2025 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Evaluation of Severe Oral Mucositis in Locally Advanced Unresectable Head and Neck Squamous Cell Carcinoma HNSCC Patients Treated by Chemoradiotherapy CTRT Using Volumetric Modulated ARC Therapy VMAT with Simultaneous Integrated Boost SIB A Single Institution Prospective Study

Head and neck carcinomas are the most common cancer in India with oral cavity being the most common subsite and squamous cell carcinoma being the most common histology. After 1970s Radiotherapy RT became the primary treatment modalities of head and neck squamous cell carcinoma HNSCC except Oral cavity often in combination with chemotherapy. RT plays major role in loco regional control in HNSCC.

Radiotherapy is delivered by using varying techniques. IMRT VMAT plays a critical role in the management of patients with head and neck HN cancer. The advantage of IMRT VMAT over older conventional techniques is that it can conform the dose to any complex target volume and avoid critical Organs at Risk OARs.

Oral mucositis is a frequent and distressing complication of adjuvant RT in patients treated for head and neck cancers. It significantly impairs oral intake quality of life and may necessitate treatment breaks thereby compromising oncologic outcomes. After MACHNC metaanalysis CTRT became the cornerstone of treatment of locally advanced HNSCC. The loco regional control survival outcome and toxicity depend on multiple factors. In this prospective study we have tried to correlate various host factors tumour factors and laboratory values to the survival outcome and toxicity. This study will prospectively analyse Institute patient data and tally this with western data and other Indian population data to compare severe RT induced oral mucositis rate RTOG grade grade 3 evaluate QoL by Mouth and Throat soreness score MTS and QLQC30 HN questioner and assess the need of feeding tube hospitalization rate opioid use and significant weight loss 5 kg and evaluate impact of various host and tumour related factor with treatment outcome and survival.

 
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