| 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
|
|
|
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
|
|
|
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
|
|
|
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. |