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CTRI Number  CTRI/2025/04/084548 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Radiation Therapy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Two Types of Radiation Therapy for Nasal Cancer 
Scientific Title of Study   A Prospective, Phase II, Randomized Controlled Trial of Intensity Modulated Radiation Therapy (IMRT) versus Intensity Modulated Proton Therapy (IMPT) in Nasopharyngeal Carcinoma 
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 Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room number 1126,11th floor, Department of Head and Neck Radiation Oncology, Homi Bhabha Block, Tata Memorial Hospital Parel Mumbai, India

Mumbai
MAHARASHTRA
400012
India 
Phone  9820834386  
Fax  24146937  
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room number 1126,11th floor, Department of Head and Neck Radiation Oncology, Homi Bhabha Block, Tata Memorial Hospital Parel Mumbai, India


MAHARASHTRA
400012
India 
Phone  9820834386  
Fax  24146937  
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sarbani Ghosh Laskar 
Designation  Professor Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room number 1126,11th floor, Department of Head and Neck Radiation Oncology, Homi Bhabha Block, Tata Memorial Hospital Parel Mumbai, India


MAHARASHTRA
400012
India 
Phone  9820834386  
Fax  24146937  
Email  sarbanilaskar@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Research Administration Council(TRAC), Main building, 3rd Floor, Tata Memorial Hospital, Dr. E Borges Road Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Tata Memorial Centre Research Administration Council 
Address  Main building 3rd Floor,Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai 400012, Maharashtra, India 
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 Sarbani Ghosh Laskar  Tata Memorial Hospital  Head and Neck Radiation OPD 206 Homi Bhabha Block, Head and Neck Radiation OPD 109 Golden Jubilee Building, Tata Memorial Hospital, Dr E Borges Road Parel, Mumbai 400012, MAHARASHTRA, India
Mumbai
MAHARASHTRA 
9820834386
24146937
sarbanilaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommittee- 1,Tata MemorialCentre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intensity Modulated Proton Therapy  IMPT is a sophisticated type of proton therapy used in cancer treatment, similar to Intensity-Modulated Radiation Therapy (IMRT). It allows for precise targeting of tumors while minimizing damage to surrounding healthy tissues. 
Comparator Agent  Intensity-Modulated Radiation Therapy  Intensity-Modulated Radiation Therapy is a type of radiation therapy that uses computer-controlled linear accelerators to deliver precise radiation doses to a tumor, while minimizing damage to surrounding healthy tissues. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients diagnosed with histopathologically confirmed NPC: squamous, undifferentiated or poorly differentiated carcinoma
2.Age more than or equal to 18 years
3.Stage II-IVA NPC (as per the 8th AJCC staging)
4.Planned for treatment with curative intent
5.Willing to undergo treatment at TMC Proton Therapy Centre
6.Willing to give informed consent
7.Patients who have received standard neoadjuvant chemotherapy outside/TMH and have a baseline pre-treatment imaging and staging information available
 
 
ExclusionCriteria 
Details  1.Patients with oligometastatic or metastatic disease
2.Other nasopharyngeal histopathologies like sarcomas, adenocarcinoma, lymphoma etc.
3.Significant comorbidities precluding combined modality treatment with chemotherapy and/or radiotherapy
4.Patients with synchronous or metachronous primary
5.Patients who have received prior RT to the head and neck region
6.Patients with pre-existing significant salivary gland pathology
7.Incompletely or partially treated NPC
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Progression-free survival (PFS) and overall survival (OS)   Progression-free survival (PFS) and overall survival (OS) at 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient reported xerostomia and hearing loss post treatment in both the arms
 
baseline, RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion  
Objective evaluation of xerostomia using salivary scintigraphy post RT in both the arms  baseline, 3 months, 6 months, 1 year and 2 years post RT completion 
Comparison of other radiation-related acute- and late-toxicities in both the arms
 
evaluated on treatment, at conclusion, 3 months, 6 months, 1 year and 2 years post RT completion  
To assess Quality of Life (QoL) in both the arms   baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion. 
To assess the cost effectiveness of IMPT over IMRT  baseline, at RT conclusion, 3 months, 6 months, 1 year and 2 years post RT completion. 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 
Date of First Enrollment (India)   01/05/2025 
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="8"
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  

Nasopharyngeal Carcinoma (NPC) is a rare type of epithelial cancer originating from the nasopharynx lining, with distinct epidemiological features. It is most common in Southern China and Southeast Asia, while in India, its prevalence is notably higher in the North-Eastern states.

NPC often affects younger patients and shows high radiosensitivity, making radiotherapy (RT) the primary treatment. Historically, treatment evolved from 2D-RT to 3D-CRT, and now Intensity Modulated Radiation Therapy (IMRT) is the standard due to its precision and reduced toxicity to normal tissues.

Despite the success of IMRT in improving survival and reducing side effects like xerostomia and hearing loss, 30-40% of patients still suffer from moderate to severe late toxicities, which negatively impact long-term quality of life (QoL).

To enhance outcomes and reduce side effects further, chemotherapy has been combined with RT, especially in advanced-stage NPC, as proven by landmark trials like Intergroup 0099, NPC-9901, and NPC-0501. Neoadjuvant chemotherapy (NACT) followed by concurrent chemoradiotherapy (CRT) is now considered the standard for Stage III–IVA NPC.

A promising alternative is Intensity Modulated Proton Therapy (IMPT), an advanced form of Proton Beam Therapy (PBT). Due to the unique physical properties of protons (sharp dose fall-off), IMPT can deliver high tumor doses while sparing surrounding healthy tissues. Early clinical and dosimetric studies show IMPT may significantly reduce toxicities (e.g., xerostomia, hearing loss) and improve QoL compared to IMRT.

However, evidence from randomized trials is lacking, especially in Indian populations. Therefore, a Phase II Randomized Controlled Trial is proposed to compare IMRT vs. IMPT in NPC, aiming to establish stronger evidence on reducing long-term toxicity and improving patient outcomes.

 
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