| 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
|
|
|
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
|
|
|
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 IIIāIVA 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. |