| CTRI Number |
CTRI/2025/10/096230 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment Outcome of Head and Neck Cancer Patients with Extranodal Extension treated with Advanced Radiotherapy and Chemotherapy |
|
Scientific Title of Study
|
Treatment Outcome of Patients with Regionally Advanced Head and Neck Squamous Cell Carcinoma with Clinical Extranodal Extension Treated with Definitive Chemoradiation: A Prospective Single-Arm Study |
| Trial Acronym |
N3B |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotiman Nath |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. Borooah Cancer Institute, Guwahati, Assam |
| Address |
Department of Radiation Oncology, Dr. B. Borooah Cancer Institute, A. K. Azad Road, Gopinath Nagar, Guwahati, Assam
Kamrup
ASSAM
781016
India |
| Phone |
9401512763 |
| Fax |
|
| Email |
jyotimannath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyotiman Nath |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. Borooah Cancer Institute, Guwahati, Assam |
| Address |
Department of Radiation Oncology, Dr. B. Borooah Cancer Institute, A. K. Azad Road, Gopinath Nagar, Guwahati, Assam
Kamrup
ASSAM
781016
India |
| Phone |
9401512763 |
| Fax |
|
| Email |
jyotimannath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotiman Nath |
| Designation |
Associate Professor |
| Affiliation |
Dr. B. Borooah Cancer Institute, Guwahati, Assam |
| Address |
Department of Radiation Oncology, Dr. B. Borooah Cancer Institute, A. K. Azad Road, Gopinath Nagar, Guwahati, Assam
Kamrup
ASSAM
781016
India |
| Phone |
9401512763 |
| Fax |
|
| Email |
jyotimannath@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Radiation Oncology BBCI |
| Address |
Dr. B. Borooah Cancer Institute, A. K. Azad Road, Gopinath Nagar, Guwahati, Assam, India- 781016 |
| 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 Jyotiman Nath |
Dr. B. Borooah Cancer Institute, Guwahati, Assam |
Department of Radiation Oncology, Dr. B. Borooah Cancer Institute, A. K. Azad Road, Gopinath Nagar, Guwahati, Assam, India- 781016
Kamrup
ASSAM |
09401512763
jyotimannath@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: C139||Malignant neoplasm of hypopharynx,unspecified, (2) ICD-10 Condition: C329||Malignant neoplasm of larynx, unspecified, (3) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Histologically confirmed inoperable SCC of oropharynx, hypopharynx, or larynx with cN3b nodal status.
2. ECOG performance 0–1
3. Age 18–70 years
4. Written Informed Consent Obtained
|
|
| ExclusionCriteria |
| Details |
1. Nodal disease with skin ulceration/fungation/bleeding
2. Prior Radiotherapy for head and neck area
3. Deranged renal function at baseline (Creatinine Clearance less than 50 ml/min)
4. Cases with radiological evidence of Cartilage or Bony Erosion
5. Baseline Non-Functional Larynx based on FEES Test
6. Unable to come for follow-up as per study protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the progression-free survival (PFS) at 2 year
|
To assess the progression-free survival (PFS) at 2 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate treatment related toxicities during radiotherapy, at completion and at every follow up using CTCAE 5.0 scale
During and at the end of Radiotherapy- Oral mucositis, Dermatitis, Dysphagia, Acute Xerostomia, Neutropenia, Thrombocytopenia, Anaemia, Electrolyte imbalance
At follow ups- Xerostomia, Subcutaneous Fibrosis, Dysphagia
|
|
To measure the QOL using instruments (Validated QOL Instruments)
EORTC QOL tool QLQ-C30 Quality of Life of Cancer Patients (in English and Assamese)
QLQ-H&N35 specific for Head and neck cancer (In English and Assamese)
Patient reported HRQOL will be recorded at baseline and at 3 months,6 months and 1 year after completion of Radiotherapy.
|
at baseline, 3 months, 6 months, and 1 year post RT completion |
| To estimate various prognostic factors associated with treatment response eg. Age, Gender, Size of the Node, T-stage, HPV status for oropharyngeal primary, history of smoking, alcohol consumption etc. |
|
to estimate the Patterns of Failure:-
1. Locoregional Failure
2. Distant Metastases
|
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
03/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Head and Neck Squamous Cell Carcinoma (HNSCC) is among the most common cancers in India, with a high burden in the North Eastern region. A large proportion of patients present with locally advanced disease involving lymph nodes with extranodal extension, which is classified as clinical N3b according to AJCC 8th edition. This subset carries a poor prognosis, and there is no established standard of care for patients with clinical N3b disease.
This prospective single arm study aims to evaluate treatment outcomes in patients with locally advanced inoperable head and neck squamous cell carcinoma with clinical extranodal extension treated with definitive concurrent chemoradiation using modern conformal radiotherapy techniques.
Eligible patients aged 18 to 70 years with ECOG performance status 0 or 1 and histologically confirmed squamous cell carcinoma of oropharynx, hypopharynx or larynx with clinical N3b status will be included. Patients with prior head and neck radiotherapy, renal dysfunction or ulcerated nodes will be excluded.
All patients will receive Volumetric Modulated Arc Therapy (VMAT) based radiotherapy to a total dose of 66 Gray to the high risk volume, 60 Gray to intermediate risk and 54 Gray to low risk volumes in 30 fractions over six and a half weeks. Concurrent weekly cisplatin at 40 milligrams per square meter will be administered to achieve a cumulative dose of at least 200 milligrams per square meter.
The primary endpoint is two year progression free survival. Secondary endpoints include treatment related toxicity assessed by CTCAE version 5.0, quality of life assessment using EORTC QLQ C30 and HN35 questionnaires, and analysis of prognostic factors such as age, sex, nodal size and HPV status.
Sample size is 45 patients, based on an expected improvement in two year progression free survival from 7.5 percent in historical data to 25 percent with modern radiotherapy. Statistical analysis will use Kaplan Meier method and log rank test.
The study will be conducted in the Department of Radiation Oncology, Dr B Borooah Cancer Institute, Guwahati. Data will be monitored by the institutional Data Monitoring and Safety Unit. The study is expected to generate evidence on the role of advanced radiotherapy in improving outcomes for patients with regionally advanced head and neck cancer with extranodal extension. |