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CTRI Number  CTRI/2026/02/102999 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   A Study to Evaluate a New International Radiation Planning Guideline in Patients with Nasopharyngeal Cancer 
Scientific Title of Study   Implementation and Outcome Assessment of the 2024 International Clinical Target Volume Delineation Guideline in Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Clinical Study 
Trial Acronym  ImpACT-NPC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yanpothung Yanthan 
Designation  Assistant Professor 
Affiliation  Dr. B. Borooah Cancer Institute 
Address  Department of Radiation Oncology Dr. B. Borooah Cancer Institute
Gopinath Nagar Rd Guwahati
Kamrup
ASSAM
781016
India 
Phone  9612551001  
Fax    
Email  yanyanthan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Yanpothung Yanthan 
Designation  Assistant Professor 
Affiliation  Dr. B. Borooah Cancer Institute 
Address  Department of Radiation Oncology Dr. B. Borooah Cancer Institute
Gopinath Nagar Rd Guwahati
Kamrup
ASSAM
781016
India 
Phone  9612551001  
Fax    
Email  yanyanthan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yanpothung Yanthan 
Designation  Assistant Professor 
Affiliation  Dr. B. Borooah Cancer Institute 
Address  Department of Radiation Oncology Dr. B. Borooah Cancer Institute
Gopinath Nagar Rd Guwahati
Kamrup
ASSAM
781016
India 
Phone  9612551001  
Fax    
Email  yanyanthan@gmail.com  
 
Source of Monetary or Material Support  
Dr B Borooah Cancer Institute Gopinath Nagar, Guwahati -781016 Assam, India 
 
Primary Sponsor  
Name  Yanpothung Yanthan 
Address  Dr B Borooah Cancer Institue A K Azad Road, Gopinath Nagar Guwahati -781016, Assam 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Abhinandan Das  Dr B Borooah Cancer Institue A K Azad Road, Gopinath Nagar Guwahati -781016, Assam 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Yanpothung Yanthan  Dr B Borooah Cancer Institute  AK Azad Road Gopinath Nagar Guwahati
Kamrup
ASSAM 
9612551001

yanyanthan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medical Ethics Committee, BBCI  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  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Biopsy-proven nasopharyngeal carcinoma.
Age 18 to 70 years.
Stage II to IVA disease (AJCC 9th edition).
ECOG performance status 0 to 1
Eligible for induction chemotherapy followed by concurrent chemoradiation.
Capable of providing written or witnessed informed consent 
 
ExclusionCriteria 
Details  Prior head and neck radiotherapy.
Previous head and neck malignancy regardless of interval since diagnosis.
Previous Non-Head and Neck malignancy (excluding basal cell carcinoma) with disease free interval less than 10 years.
Uncontrolled comorbidities or pregnancy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the 2-year locoregional failure-free survival (LR-FFS) in NPC patients treated using IG-2024 CTV delineation.  To estimate the 2-year locoregional failure-free survival (LR-FFS) in NPC patients treated using IG-2024 CTV delineation. 
 
Secondary Outcome  
Outcome  TimePoints 
• To estimate the incidence and severity of acute and late toxicities using CTCAE v6.0  Acute till 3 months after treatment completion.
Late after 3 months 
• To analyse dosimetric parameters, including PTV/CTV/GTV coverage and OAR dose metrics.  At the time of radiotherapy planning 
• To compare the estimated 2-year LR-FFS, toxicities, and dosimetric parameters with historical benchmarks based on IG-2018.  Acute toxicity till 3 months after treatment completion.
Late after 3 months. 2 years LR-FFS 
 
Target Sample Size   Total Sample Size="55"
Sample Size from India="55" 
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)   10/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 cancer that develops in the nasopharynx, an area located behind the nose and above the throat. Treating NPC is challenging because this region lies very close to important organs such as the brain, eyes, nerves, and salivary glands. Radiation therapy is the main treatment for NPC and is highly effective, but it must be planned with great precision to destroy the cancer while minimizing damage to nearby healthy tissues.

To ensure consistency and safety in radiation treatment planning, international expert groups have developed guidelines that define how radiation oncologists should outline the areas that need to be treated with radiation. The 2018 international guideline (IG-2018) has been widely used in routine practice. In recent years, however, the treatment of NPC has evolved. Many patients now receive chemotherapy before radiation therapy, known as neoadjuvant or induction chemotherapy. This often causes the tumor to shrink significantly before radiation treatment begins.

Because of this change in treatment approach, an updated international guideline (IG-2024) was released in 2025. This new guideline recommends using imaging done after chemotherapy to define the radiation target areas more accurately. It also suggests smaller safety margins and refined dose levels, with the goal of maintaining good cancer control while reducing radiation exposure to normal tissues. By doing so, the guideline aims to lower the risk of side effects such as dry mouth, hearing problems, and nerve damage, which can affect long-term quality of life.

Although IG-2024 is based on strong scientific evidence and expert consensus, its use has not yet been prospectively evaluated in real-world clinical settings in India. This is especially important in Northeast India, where NPC is more common than in most other parts of the country.

This study will be carried out at a tertiary cancer centre in Northeast India. Patients receiving standard treatment for NPC will be treated using radiation plans designed according to the IG-2024 guideline. No experimental drugs or additional procedures are involved. Patients will be followed during treatment and for at least two years afterward to assess how well the cancer is controlled and to record any treatment-related side effects.

The results of this study will help determine whether IG-2024 can be safely and effectively used in routine clinical practice in this region. Participation is voluntary, and all patient information will be kept confidential.

 
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