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Carotid Artery Sparing Radiotherapy in Early Laryngeal Cancers: A single centre Phase 2 study to assess feasibility of implementing carotid sparing intensity modulated radiotherapy techniques with image guidance in Early Laryngeal Cancers

Carotid Artery Sparing Radiotherapy in Early Laryngeal Cancers - CARSREL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003243
Enrollment
30
Registered
2012-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Head and Neck Squamous Cell Carcinoma

Interventions

Intervention1: Radiotherapy with carotid sparing: Using Helical tomotherapy - treating to a dose of 55Gy in 20 fractions, also sparing of carotid artery to be done during planning process.(Overall ti

Sponsors

Tata Medical Center Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Tomotherapy group ALL of: Adult patients Squamous Cell CA of the glottis Suited to have radical radiotherapy Who gives informed consent T1 or T2 tumour of the Glottis No neck nodal involvement Suited to receive 55Gy in 20 fractions Control group: Any patient needing radiotherapy without carotid sparing, to the neck

Exclusion criteria

Exclusion criteria: Any of the above criteria not met Previous Radiotherapy to head or neck Known carotid arterial disease

Design outcomes

Primary

MeasureTime frame
Primary Endpoint: Feasibility of clinical implementation of image guided Tomotherapy The percentage change in the intimal thickness following radiotherapy The percentage difference in mean % carotid artery intimal thickness following radiotherapy in the two groups Timepoint: pre treatment, 6m, and 18 months post treatment for carotid scans 1 year for accrual

Secondary

MeasureTime frame
To identify if maximum dose to the carotids would predict changes on Doppler as opposed to higher (35Gy) median or mean dose To identify if carotid Doppler at 6 months could predict longer term changes in carotid intimal thickness Timepoint: 6months and 18 months post radiotherapy

Countries

India

Contacts

Public ContactDr Sanjoy Chatterjee
sanjoy.chatterjee@tmckolkata.com

Outcome results

None listed

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