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Phase 2
Age: 18Years - 80Years
All Genders
ID04277858

Phase II Study of Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Treating HPV-Positive Oropharyngeal Cancer

Led by Nader Sadeghi · Updated on 2023-10-23

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for human papilloma virus HPV related oropharyngeal cancer, focusing on advanced stages III and IV of oropharyngeal squamous cell carcinoma positive for p16. This study aims to compare the effectiveness of neoadjuvant chemotherapy followed by Transoral Robotic Surgery TORS and neck dissection with the current standard treatment of chemoradiotherapy, which has significant lifelong side effects and a 20% failure rate. The goal is to achieve similar or better cure rates with fewer side effects and improved quality of life. Participants will receive three cycles of neoadjuvant chemotherapy using docetaxel and cisplatin or carboplatin as an alternative, followed by transoral robotic surgery and neck dissection to remove the cancer. This approach is designed to avoid or reduce the need for radiotherapy, which often causes long-term complications. Radiotherapy will be reserved only for salvage treatment if needed. This study represents a new treatment paradigm aiming to improve functional outcomes and reduce the harmful effects caused by radiation. During the trial, participants will be monitored for progression-free survival over two years, with additional assessments of disease-specific and overall survival over five years. Quality of life will be evaluated over 12 months using general and head and neck specific measures. Researchers will assess the effectiveness of the treatment and its impact on patients function and well-being. Participants will undergo surgery, chemotherapy, and regular follow-ups to track cancer status and side effects throughout the study period.

CONDITIONS

Brief Title

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Research Team

N

Nader Sadeghi, MD

E

Elizabeth Beaubien

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