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
Phase 2
- Conditions
- Health Condition 1: null- Head and Neck Squamous Cell Carcinoma
- Registration Number
- CTRI/2012/12/003243
- Lead Sponsor
- Tata Medical Center Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 30
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
Any of the above criteria not met
Previous Radiotherapy to head or neck
Known carotid arterial disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint: <br/ ><br>Feasibility of clinical implementation of image guided Tomotherapy <br/ ><br>The percentage change in the intimal thickness following radiotherapy <br/ ><br>The percentage difference in mean % carotid artery intimal thickness following radiotherapy in the two groups <br/ ><br>Timepoint: pre treatment, 6m, and 18 months post treatment for carotid scans <br/ ><br>1 year for accrual <br/ ><br>
- Secondary Outcome Measures
Name Time Method To identify if maximum dose to the carotids would predict changes on Doppler as opposed to higher (35Gy) median or mean dose <br/ ><br>To identify if carotid Doppler at 6 months could predict longer term changes in carotid intimal thickness <br/ ><br>Timepoint: 6months and 18 months post radiotherapy