A Study Comparing Side Effects and Quality of Life in Short vs Long Course Chemoradiation for Unresectable Oral Cancers

A Phase III Randomized Controlled Trial Evaluating Toxicity and Quality of Life between a Short Course of Hypofractionated versus Conventionally fractionated Chemoradiation for Locally Advanced Unresectable Oral Cancers - SHyne

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/077881

Enrollment

388

Registered

2024-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Short Course RT Arm: Intervention arm will receive a short course hypofractionated RT to a dose of 55 Gy/20# over 4 weeks with IMRT and weekly concurrent chemotherapy Control Interventi

Eligibility

Inclusion criteria

Inclusion criteria: -Biopsy-proven, treatment-naïve, non-metastatic, inoperable patients with locally advanced oral cavity SCC (Stage IV, AJCC 8th edition) -Deemed Unresectable in Multidisciplinary tumour board -KPS = 70 -Fit for concurrent chemotherapy

Exclusion criteria

Exclusion criteria: -Recurrent oral cancers -Gross mandibular erosion -Orocutaneous fistula -Involvement of the whole tongue by disease -History of prior radiation therapy -Severe comorbidities (ACE -27 = 2)

Design outcomes

Primary

Measure	Time frame
-Acute toxicities will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 questionnaire. -Quality of life will be measured using the Functional Assessment of Cancer Therapy- Head & Neck (FACT-HN) questionnaire.Timepoint: Acute Toxicities will be assessed weekly during treatment, at the end of treatment, and three months post treatment completion. Quality of Life will be evaluated at baseline, at the end of treatment, and three months post treatment completion.	—

Measure

Time frame

-Acute toxicities will be measured using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 questionnaire. -Quality of life will be measured using the Functional Assessment of Cancer Therapy- Head & Neck (FACT-HN) questionnaire.Timepoint: Acute Toxicities will be assessed weekly during treatment, at the end of treatment, and three months post treatment completion. Quality of Life will be evaluated at baseline, at the end of treatment, and three months post treatment completion.

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Secondary

Measure	Time frame
-Overall survival (OS) -Progression-free survival (PFS) -Late toxicitiesTimepoint: OS: From the date of randomization until death due to any cause PFS: From the date of randomization until locoregional/distant progression or death due to any cause Late Toxicities: Evaluated with CTCAE Version 5 questionnaire after 90 days of treatment completion	—

Countries

India

Contacts

Public ContactAnuj Kumar S

ACTREC, Tata Memorial Centre

anujkumar.tvm@gmail.com9946416480

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026