| 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
|
|
|
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. |