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Quality of Life After Conformal Radiotherapy in Late Stage Oral Cavity Cancer:A Prospective clinical Trial

Effect of Hypofractionated Palliative Radiotherapy on Quality of Life in Late Stage Oral Cavity Cancer:A Prospective clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012441
Enrollment
53
Registered
2018-03-08
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- Carcinoma Oral Cavity Stage IV A and IV B fit for palliative treatment

Interventions

Intervention1: Hypofractionated Palliative Radiotherapy: Hypofractionated Radiotherapy(5250 cGy/15 fractions) will be given for patients with late stage Oral cavity cancer ( Stage IVA and IV B) and th

Sponsors

Jawaharlal Institue of Postgraduate Medical Education and research
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: i)Patients with another primary at a different site ii)Pregnant women iii)Age 80 years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 ;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

Countries

India

Contacts

Public ContactDr Aswin Chandran V

Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)

shyamagopalakrishnan@yahoo.co.in9345324215

Outcome results

None listed

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