Comparison of two radiation treatment schedules to reduce symptoms in advanced head and neck cancer patients
- Conditions
- Health Condition 1: C00-D49- Neoplasms
- Registration Number
- CTRI/2023/02/049783
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Age between 18 to 80 years
-Histopathologically diagnosed as squamous cell carcinoma
-Cancer of head and neck involving the following sub-sites:-
o Oral cavity
o Oropharynx
o Hypo-pharynx
o Larynx
-De-novo or recurrent / refractory cases
-Clinically stage group III to IVC (AJCC 8th Edition)
-ECOG PS 0 to 3
-Deemed unsuitable for surgery / inoperable in a multidisciplinary tumour board
-Calculated life expectancy > 90 days
-Baseline Haemoglobin >9 gm/dl, ANC > 1500/µl, platelets > 1,00,000/µl
-Creatinine Clearance >30 ml/min
-Written informed consent
-Histopathology other than squamous cell carcinoma
-Pregnancy and lactation
-Uncontrolled severe comorbidities
-Severe dyselectrolytaemia
-Sub-sites other than Oral cavity, Oropharynx, Hypo-pharynx and Larynx
-Major psychiatric illness making the patient incapable of following medical advice
-Prior head and neck radiotherapy within the last 6 months
-Prior head and neck surgery within the last 3 months
-Concomitant or prior chemotherapy / targeted therapy / immunotherapy within the last 2
weeks
-Inability to receive palliative radiotherapy due to patient’s clinical condition, positional
or immobilization issues or other reasons
-Unwillingness to undergo palliative radiotherapy
-Refusal to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method QUAD SHOT IS AN EFFECTIVE PALLIATIVE REGIMEN FOR ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA.Timepoint: AT BASELINE, DAY 3, DAY 7, DAY 28, SUBSEQUENTLY IN EVERY MONTHS.
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI