| CTRI Number |
CTRI/2026/01/102110 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing Hypofractionated radiotherapy versus conventional chemoradiation IN Elderly patients with locally advanced head and neck squamous cell carcinoma(SHINE trial): A Phase II open label randomized controlled trial |
|
Scientific Title of Study
|
Study comparing Hypofractionated radiotherapy versus conventional chemoradiation IN Elderly patients with locally advanced head and neck squamous cell carcinoma (SHINE trial):A Phase II open label randomized controlled trial |
| Trial Acronym |
SHINE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anamika Chandra |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
1ST FLOOR, ROOM NO 142, RT WARD, DR. B.R.A. IRCH BUILDING,AIIMS NEW DELHI
RT WARD, DR. B.R.A. IRCH BUILDING,AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9664417526 |
| Fax |
|
| Email |
anamika.rihand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali V R |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
ROOM NO 143,1ST FLOOR,RT WARD, DR. B.R.A. IRCH BUILDING,AIIMS NEW DELHI
1ST FLOOR,RT WARD, DR. B.R.A. IRCH BUILDING,AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9446948374 |
| Fax |
|
| Email |
dr.anjali.v.ramdulari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anjali V R |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
1ST FLOOR, ROOM NO 143, RT WARD, DR. B.R.A. IRCH BUILDING,AIIMS NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9446948374 |
| Fax |
|
| Email |
dr.anjali.v.ramdulari@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
All India Institute of Medical Sciences
Ansari Nagar East
New Delhi - 110029 |
| 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 Anamika Chandra |
AIIMS, NEW DELHI |
1st floor, RT ward
Dept of Radiation Oncology
DR.BRAIRCH AIIMS, New Delhi
New Delhi
DELHI |
9664417526
anamika.rihand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C138||Malignant neoplasm of overlappingsites of hypopharynx, (3) ICD-10 Condition: C328||Malignant neoplasm of overlappingsites of larynx, (4) ICD-10 Condition: C108||Malignant neoplasm of overlappingsites of oropharynx, (5) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (6) ICD-10 Condition: C098||Malignant neoplasm of overlappingsites of tonsil, (7) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional chemoradiotherapy in elderly locally advanced head and neck squamous cell carcinoma patients treated with radical intent |
Conventional chemoradiation 65Gy in 30 fractions to high risk PTV, and 54 Gy in 30 fractions to low risk PTV with 6MV photons SIB-VMAT technique over 6 weeks with concurrent weekly cisplatin |
| Intervention |
Hypofractionated radiotherapy in elderly locally advanced head and neck squamous cell carcinoma patients treated with radical intent |
Hypofractionated radiotherapy 57.2Gy in 22 fraction over 4 ½ weeks to high risk PTV and 47 Gy in 22 fractions to low risk PTV over 4 ½ week with 6MV photons with SIB-VMAT technique. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 65-75
Eastern Co-operative Oncology Group Performance Score (ECOG PS) 0-2
Biopsy proven locally advanced squamous cell carcinoma of head and neck region including oropharynx, larynx, hypopharynx and oral cavity.
Absence of uncontrolled medical comorbidity.
Adequate end organ functions &bone marrow reserve.
Written Informed consent. |
|
| ExclusionCriteria |
| Details |
Age less than 65 or more than 75
Eastern Co-operative Oncology Group Performance Score (ECOG PS) 3-4
Locally advanced biopsy proven squamous cell carcinoma of nasopharyngeal, para-nasal sinus and salivary gland primary.
Any prior oncological treatment with surgery, chemotherapy or radiotherapy.
Any uncontrolled comorbidity which may compromise delivery of protocol defined chemotherapy and radiotherapy e.g., renal disease, cardiorespiratory disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment Response rate |
3 months post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Locoregional progression free survival |
3,6,12 months post treatment |
| Overall survival |
3,6,12 months post treatment |
| Distant metastasis free survival |
3,6,12 months post treatment |
| Treatment related acute toxicity |
Weekly during treatment and 1 month post treatment |
| Treatment related late toxicity |
3, 6 and 12 months post treatment |
| Quality of Life |
Baseline and 3, 6 and 12 months post treatment |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/02/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Elderly patients with advanced head and neck cancer represent a vulnerable population with their unique physiological challenges and comorbidities, requiring tailored approach to address their specific needs. Hypo fractionated radiotherapy has shown promise in improving treatment outcomes, reducing toxicity, and enhancing quality of life for various solid tumors. Hypofractionated treatments in elderly subset has possibility of improving treatment outcomes with reduced acute toxicities and faster treatment delivery improving overall quality of care. |