April 12 2023
Written by Stuart Wong, MD
The NRG Oncology Head and Neck Committee has a tradition of over half a century of pioneering leadership in scientific innovation. The very earliest trials from this committee, under the legacy organization RTOG, were conducted in the same era as the first lunar missions. Looking back, these seminal head and neck trials conveyed a similar spirit as the Apollo missions of exploration, excitement, and trepidation. The earliest of these investigations tested groundbreaking experimental concepts such as neoadjuvant therapy, concurrent therapy, and altered fractionated radiation. In the subsequent decades, many practice changing head and neck trials have been published by this group. These efforts were led by multi-disciplinary teams of investigators, many who were giants in their respective fields, and supported by dedicated staff, some of whom have spanned these eras. Prior leaders of the NRG (RTOG) Head and Neck Committee include Victor Marcial (a founder of RTOG), Karen Fu, Kian Ang, and Quynh Le.
Today the NRG Oncology Head and Neck Committee, led by Sue Yom, continues to push the envelope of research by producing innovative clinical trials for NRG Oncology as well as the RTOG Foundation. The Head and Neck Committee is also dedicated to the mission of mentoring the next generation of head and neck cancer leaders. The recently created Head and Neck Committee Working Groups are an exciting mechanism to develop this talent, to seek out new treatments for understudied diseases, and to boldly examine new scientific questions utilizing the unique combined resources and outreach networks of NRG Oncology and RTOG Foundation. RTOG Foundation as a developing entity offers a new set of opportunities and welcomes early-career investigators.
The collaborative efforts of the Head and Neck Committee are exemplified by many active and developing trials including the upcoming TRANSPARENT study (RTOG Foundation 3521). Under the guidance of new principal investigator Dr. Anna Spreafico, this study will enroll a total of 100 patients with histological or cytological confirmation of recurrent and/or metastatic nasopharyngeal cancer (NPC) with either EBV-associated and Human Papilloma Virus (HPV)-positive or negative or non-EBV-associated (HPV-positive or negative) cancer. To ensure adequate representation of the North American patient population, up to 30% of participants with nasopharyngeal cancer with keratinizing histology will be enrolled in this study and receive cisplatin gemcitabine plus toripalimab followed by toripalimab maintenance. This study is composed of 2 treatment phases with a total duration of up to 2 years (24 months) of treatment. The chemotherapy-based treatment phase includes the triple combination of cisplatin, gemcitabine and toripalimab for up to 6 cycles depending on response and tolerability. The maintenance treatment phase (or post-chemotherapy–based treatment phase), includes single-agent toripalimab. If this study is successful, it will be the first validation of state-of-the-art treatment for recurrent/metastatic NPC in North America.
RTOG Foundation Study 3507, KEYSTROKE trial, is a phase II study that examines SBRT re-irradiation with or without Pembrolizumab (KEYTRUDA®) for patients with locoregionally recurrent or new second primary head and neck carcinoma. This is the first large, randomized study to examine this innovative experimental therapy in a multi-center setting. This is an ongoing limited institution trial that has future practice-changing implications. This study was developed by a multidisciplinary team, Dr. Stuart Wong and Dr. Shlomo Koyfman, resulting in a new set of evidence-based dose-constraint standards and delivery parameters for stereotactic body radiation in the head and neck. If this study is successful, it will be the first validation of the role of SBRT in this setting as part of a combined therapy program.
The RTOG Foundation is a nonprofit organization dedicated to improving outcomes for cancer patients through the conduct of practice changing clinical trials. RTOG Foundation collaborates with partners from industry and federally funded programs to support its research.
More information about RTOGF 3507, RTOGF 3521, and the RTOG Foundation can be found below:
https://www.rtog.org/Clinical-Trials/Foundation-Studies/3507
RTOGF 3521 Webpage Coming Soon!
https://www.rtog.org/