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Search / Trial NCT05648461

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

Trial Information

Current as of January 13, 2025

Not yet recruiting

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.

About All India Institute Of Medical Sciences, New Delhi

The All India Institute of Medical Sciences (AIIMS) in New Delhi is a premier medical research institution and a leading clinical trial sponsor in India. Renowned for its commitment to advancing healthcare through innovative research, AIIMS plays a pivotal role in conducting high-quality clinical trials across various medical disciplines. The institute is dedicated to enhancing patient care by integrating cutting-edge scientific research with clinical practice, ensuring rigorous adherence to ethical standards and regulatory guidelines. With a team of expert researchers and state-of-the-art facilities, AIIMS fosters collaboration and knowledge exchange to address pressing health challenges and contribute to global medical advancements.

Locations

Jhajjar, Haryana, India

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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