Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNader Sadeghi

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

60 Participants
are divided into 1 treatment group

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