About this trial
The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.
Eligibility criteria
Qualifiers
Squamous cell cancer of oropharynx, p 16 positive
American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)
Treatment Naive
No evidence of distant metastatic disease
Disqualifiers
Patients with advanced T4 cancer unresectable without organ preservation
P16 negative tumor
N3 disease (Stage IVB AJCC-7)
5 or more positive cervical lymph nodes at presentation
Trial design
Treatments tested in this trial
- Docetaxel
Treatment groups
Sponsors and collaborators
Nader Sadeghi
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator