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

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 - SHINE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102110

Enrollment

Registered

2026-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C01- Malignant neoplasm of base of tongue Health Condition 2: C138- Malignant neoplasm of overlappingsites of hypopharynx Health Condition 3: C328- Malignant neoplasm of overlappingsites of larynx Health Condition 4: C108- Malignant neoplasm of overlappingsites of oropharynx Health Condition 5: C028- Malignant neoplasm of overlappingsites of tongue Health Condition 6: C098- Malignant neoplasm of overlappingsites of tonsil Health Condition 7: C12- Malignant neoplasm of pyrifor

Interventions

Intervention1: Hypofractionated radiotherapy in elderly locally advanced head and neck squamous cell carcinoma patients treated with radical intent: Hypofractionated radiotherapy 57.2Gy in 22 fractio

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Treatment Response rateTimepoint: 3 months post treatment	—

Secondary

Measure	Time frame
Locoregional progression free survivalTimepoint: 3,6,12 months post treatment;Overall survivalTimepoint: 3,6,12 months post treatment;Distant metastasis free survivalTimepoint: 3,6,12 months post treatment;Treatment related acute toxicityTimepoint: Weekly during treatment and 1 month post treatment;Treatment related late toxicityTimepoint: 3, 6 and 12 months post treatment;Quality of LifeTimepoint: Baseline and 3, 6 and 12 months post treatment	—

Measure

Time frame

Locoregional progression free survivalTimepoint: 3,6,12 months post treatment;Overall survivalTimepoint: 3,6,12 months post treatment;Distant metastasis free survivalTimepoint: 3,6,12 months post treatment;Treatment related acute toxicityTimepoint: Weekly during treatment and 1 month post treatment;Treatment related late toxicityTimepoint: 3, 6 and 12 months post treatment;Quality of LifeTimepoint: Baseline and 3, 6 and 12 months post treatment

—

Countries

India

Contacts

Public ContactDr Anjali V R

AIIMS New Delhi

dr.anjali.v.ramdulari@gmail.com9446948374

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026