Quality of Life After Conformal Radiotherapy in Late Stage Oral Cavity Cancer:A Prospective clinical Trial
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Carcinoma Oral Cavity Stage IV A and IV B fit for palliative treatment
- Registration Number
- CTRI/2018/03/012441
- Lead Sponsor
- Jawaharlal Institue of Postgraduate Medical Education and research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
i)Biopsy proven Squamous cell carcinoma
ii)Surgically unresectable stage IVB oral cavity cancer where oral cavity is defined as consisting of lip, alveolus, floor of mouth, hard palate, retromolar trigone, buccal mucosa and tongue (extension to infratemporal fossa extension,masticator space, pterygoid plates, or skull bases or encases internal carotid artery )
iii)Stage IVA disease- not fit for surgery/ curative treatment
iv)Stage IVC disease-for palliation of local symptoms
v)No previous history of radiotherapy/chemotherapy/surgery
vi)No previous history of cancer
Exclusion Criteria
i)Patients with another primary at a different site
ii)Pregnant women
iii)Age <18 and >80 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of hypofractionated palliative radiotherapy on quality of life in patients with late stage oral cavity cancer with the EORTC H&N 35 questionnaire with specific attention to pain,swallowing and mouth opening sub scalesTimepoint: 2 months
- Secondary Outcome Measures
Name Time Method Compliance to the treatment regimenTimepoint: 6 months;Acute toxicity during radiation therapy â?? using RTOG/CTCAE grading.Timepoint: 2 months;Assessment of general quality of life as per the QLQ C30 and other parameters in the H&N 35Timepoint: 2 months <br/ ><br>;Late toxicity using RTOG/CTCAE grading14Timepoint: 6 months;Median survivalTimepoint: 6 months;The response rates as assessed by the RECIST guidelines 1.1-complete, partial, overall response ratesTimepoint: 2 months <br/ ><br>