Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Summary

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.

Timeline

Start

2018-08-14

Primary completion

2024-08-30

Completion

2026-08-30

Publications

• Background Sadeghi N, Mascarella MA, Khalife S, Ramanakumar AV, Richardson K, Joshi AS, Taheri R, Fuson A, Bouganim N, Siegel R. Neoadjuvant chemotherapy followed by surgery for HPV-associated locoregionally advanced oropharynx cancer. Head Neck. 2020 Aug;42(8):2145-2154. doi: 10.1002/hed.26147. Epub 2020 Mar 25.
• Background Sadeghi N, Khalife S, Mascarella MA, Ramanakumar AV, Richardson K, Joshi AS, Bouganim N, Taheri R, Fuson A, Siegel R. Pathologic response to neoadjuvant chemotherapy in HPV-associated oropharynx cancer. Head Neck. 2020 Mar;42(3):417-425. doi: 10.1002/hed.26022. Epub 2019 Nov 27.
• Background Sadeghi N, Li NW, Taheri MR, Easley S, Siegel RS. Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Head Neck. 2016 Dec;38(12):1837-1846. doi: 10.1002/hed.24526. Epub 2016 Jun 14.

Drugs

Indications