Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Interventions
Intervention1: Hypofractionated accelerated chemoradiation, palliative chemoradiotherapy: 28 Gray delivered in 8 fractions, twice daily over 4 days at 3.5 Gray per fraction with concurrent cisplatin @
Sponsors
Department of Radiotherapy and Radiation Medicine Institute of Medical Sciences BHU
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically proven squamous cell carcinoma of head and neck, 2. Locally advanced unresectable disease (Stage IVA and IVB) as per AJCC 8th edition staging, 3. Age between 18 and 75 years, 4. ECOG performance status 0 to 2 at enrollment, 5. Patients unsuitable for definitive curative treatment due to extent or bulk of disease and/or comorbidities, 6. Adequate hematological, renal, and hepatic function, 7. No prior radiotherapy to the head and neck region, 8. Written informed consent obtained prior to enrollment
Exclusion criteria
Exclusion criteria: 1. Evidence of distant metastases, Nasopharyngeal carcinoma, 2. Prior radiotherapy to head and neck region, 3. Pregnant or lactating females, 4. Severe renal dysfunction or contraindication to cisplatin, 5. Any serious medical illness that may compromise patient safety or interfere with assessment of study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the degree of symptom palliation (pain, dysphagia, bleeding and airway-related symptoms) 2. To assess the acute toxicity profileTimepoint: At Baseline, 3 weeks after 1st cycle of CTRT, 3 weeks after 2nd cycle of CTRT, 3 months after completion of both cycles of CTRT | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess tumor responseTimepoint: 3 months;To evaluate quality of life changesTimepoint: 3 months;To determine progression-free survival (PFS) and overall survival (OS)Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactSunil Choudhary
Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi
Outcome results
None listed