A Prospective Randomized Controlled Trial of Functional Organ Preservation Surgery vs. Chemoradiotherapy for Head and Neck Squamous Cell Carcinoma
This prospective study compare the following items between two groups:
- Functional outcomes: laryngeal, pharyngeal, and quality of life
- Oncological outcomes: survivals, locoregional controls
- Combined imaging and molecular biomarkers with follow-up data
The functional organ preservation surgery (FOPS) is defined as a surgery preserving the
laryngeal or pharyngeal function regardless of open or transoral route. The FOPS may
- Radical tonsillectomy or other oropharyngeal resection
- Partial laryngectomy or pharyngectomy
- Transoral laser microresection
- Transoral robotic surgery (TORS)
- Reconstructive surgery may be combined with primary resection
- Neck dissection may be indicated in some patients
- Postoperative radiotherapy or chemoradiotherapy may be indicated in some patients
according to their pathologic reports.
The standard concurrent chemoradiotherapy (CRT) is generally used but radiotherapy (RT)
alone may be indicated for some patients under tumor-board discussion. The salvage surgery
may be indicated for patients with residual or recurrent diseases after CRT or RT.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Organ preservation rate
The larynge and pharyngeal functions are compared between two groups. The time frame may be extended to 5 years.
Jong-Lyel Roh, MD
Asan Medical Center
South Korea: Korea Food and Drug Administration (KFDA)