Phase II Study Exploring Five Fractions of Post-operative Radiation Therapy in Head and Neck Cancer

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI · Dec 5, 2022

Keywords

ClinConnect Summary

Radiotherapy (RT) is an integral cancer treatment and RT utilization rates for commonly occurring carcinoma include breast: 87%, cervical: 71%, head and neck: 84%, lung: 77%, and prostate: 58% \[1\]. Overall, 57.5% of global head and neck cancers occur in Asia especially in India \[2\]. Head and neck cancers in India accounted for 30% of all cancers. In India, 60 to 80% of patients present with advanced disease as compared to 40% in developed countries \[3\]. Inequitable radiotherapy availability in India leads to non-compliance in many cases, as patients need to travel long distances for t...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 or above and less than 80 years.
• • 2. Patient with high risk features: close (≤ 5mm) margin, presence of LVI or PNI, pT3-4.
• • 3. Stage pT1-4 histological confirmed carcinoma of oral cavity with intermediate high risk feature.
• • 4. Pathological N0 neck requiring ipsilateral neck PORT.
• • 5. Karnofsky performance score greater or equal 70.
• • 6. Timely delivery of PORT preferable within 6-12 weeks of surgery (additional delay of 1-3 weeks of delay beyond 12 weeks is permissible to accommodate for delayed wound healing or other logistics).
• • 7. Written informed consent for treatment.
• • 8. Available to attend long term follow- up.
• Exclusion Criteria:
• • 1. Pathologically positive neck disease.
• • 2. Positive margin.
• • 3. Patients requiring bilateral neck RT.
• • 4. Patients that require re-irradiation for recurrent disease.
• • 5. Previous radiotherapy to the head and neck region.
• • 6. Any invasive malignancy within the previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
• • 7. Age \< 18 years or \> 80 years.